Method of manufacturing an implant device and implant device

Abstract

This invention relates to a method for manufacturing an implantable device and the implantable device itself. The method for manufacturing the implantable device includes: a) preparing a flexible circuit board having at least one set of connecting terminals; b) preparing at least one electrode, each electrode having a tail electrode ring set at its proximal end and a head electrode ring set at its distal end; c) inserting the proximal end of the electrode into the corresponding set of connecting terminals of the flexible circuit board, such that the tail electrode ring set at the proximal end is electrically connected to the corresponding set of connecting terminals. This implantable device separates the electrode from the flexible circuit board, allowing the user to directly insert the electrode into the connecting terminal set of the circuit board by hand for electrical connection. This method provides reliable connection, low cost, simple manufacturing, and convenient installation and removal.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more particularly to a method for manufacturing an implantable device and the implantable device itself. Background Technology

[0002] Chronic pain has long plagued humanity, with some comparing it to a kind of cancer that never dies. Statistics show that there are at least 100 million chronic pain sufferers in China. Based on pain location, headache and facial pain account for 8.6%, neck, shoulder, and upper limb pain for 18.8%, chest and back pain for 13.2%, lower back, hip, and leg pain for 51.3%, abdominal and perineal pain for 2.9%, and generalized pain for 5.3%. The main treatments for chronic pain include physical therapy, medication, and nerve block therapy.

[0003] Currently, doctors treat pain patients using methods such as drug delivery, radiofrequency ablation, and surgery, often involving anesthetic injections. These methods have significant side effects, are highly invasive, carry high risks, and have a high failure rate. Some treatments also kill nerves, rendering the patient numb and lacking a self-protective mechanism.

[0004] Therefore, there is a need for further improvement in existing methods of pain blockade.

[0005] The information disclosed in the background section of this invention is intended only to enhance the understanding of the overall background of the invention and should not be construed as an admission or in any way implying that such information constitutes prior art known to those skilled in the art. Summary of the Invention

[0006] To address the problems existing in the prior art, the present invention provides a method for manufacturing an implantation device and an implantation device. The implantation device separates the electrode body and the flexible circuit board. The user can directly insert the electrode body into the connection terminal group of the circuit board by hand to achieve electrical connection. This method has reliable connection, low cost, simple manufacturing, and can be installed and removed relatively easily.

[0007] According to a first aspect of the present invention, a method for manufacturing an implantable device is provided, comprising: a) preparing a flexible circuit board having at least one set of connection terminals thereon; b) preparing at least one electrode body, each of the at least one electrode body having a tail electrode ring set at its proximal end and a head electrode ring set at its distal end; c) inserting the proximal end of the electrode body into a corresponding set of connection terminals of the flexible circuit board such that the tail electrode ring set at the proximal end is electrically connected to the corresponding set of connection terminals.

[0008] Preferably, the step of preparing at least one electrode body specifically includes: b1) inserting a packing tube between the first tube and the second tube, the first tube and the second tube being connected by 2n wires, the 2n wires passing through 2n peripheral cavities of the first tube and the second tube respectively and surrounding the central cavity of the first tube and the second tube, so that the 2n wires surround the packing tube and the axis of the packing tube is aligned with the axis of the first tube and the axis of the second tube; b2) inserting a mandrel through the central cavity of the first tube, the packing tube and the central cavity of the second tube so that the first tube, the packing tube and the second tube come into contact in sequence; b3) wrapping the end of the first tube near the packing tube, the 2n wires between the first tube and the second tube and the packing tube, and the end of the second tube near the packing tube with a single-cavity tube; b4) connecting the first tube, the packing tube, the second tube and the single-cavity tube to each other.

[0009] Preferably, step b1) further includes: b11) providing a first tube and a second tube, the first tube and the second tube each containing 2n+1 lumens extending along the axial direction of the tube, one of which is a central lumen located at the axis of the tube, and the remaining 2n peripheral lumens are distributed around the central lumen, where n is an integer greater than or equal to 1 and less than or equal to 8; b12) cutting 2n slits along the axial and circumferential directions of the tube on the outer walls of the first tube and the second tube in a predetermined cutting sequence and at a predetermined cutting interval, each slit exposing at least one... b13) Insert 2n wires into the 2n peripheral cavities of the first tube and the second tube respectively; b14) Pick out one end of the 2n wires from the 2n cuts on the outer wall of the first tube in a predetermined order and connect them to the 2n head electrode rings respectively. Pick out the other end of the 2n wires from the 2n cuts on the outer wall of the second tube in a predetermined order and connect them to the 2n tail electrode rings respectively. The 2n tail electrode rings form the proximal tail electrode ring group, and the 2n head electrode rings form the distal head electrode ring group.

[0010] Preferably, step b14) further includes: b141) starting from the first incision furthest from the distal end of the first tube body, picking out one end of the first wire in the first peripheral lumen; b142) slipping a first end electrode ring onto the distal end of the first tube body, so that the first end electrode ring surrounds the first tube body and covers the first incision, and is electrically connected to the picked-out end of the first wire; b143) repeating steps b141) and b142) until the 2nth end electrode ring covers the 2nth incision of the first tube body and is electrically connected to the picked-out end of the 2nth wire. b144) Starting from the first cut closest to the distal end of the second tube body, pull out the other end of the first wire in the first peripheral lumen; b145) Put the first tail electrode ring on the proximal end of the second tube body, so that the first tail electrode ring wraps around the second tube body and covers the first cut, and is electrically connected to the other end of the first wire; b146) Repeat steps b144) and b145) until the 2n tail electrode ring covers the 2n cut of the second tube body and is electrically connected to the other end of the 2n wire.

[0011] Preferably, the electrical connection between the electrode ring and the wire further includes: riveting a metal ring to one protruding end of the wire, wherein the riveted metal ring is arc-shaped and its curved surface is consistent with the inner surface of the electrode ring; and welding the metal ring to the inner surface of the electrode ring.

[0012] Preferably, the steps for fabricating the flexible circuit board specifically include: fabricating elastic connection terminals, wherein the elastic connection terminals include a support and two elastic arc plates, the two elastic arc plates are disposed at the top of the support, and the two elastic arc plates are recessed in a direction away from each other to form a clamping space, and the two elastic arc plates can provide clamping force to the electrode body inserted into the clamping space; and welding a plurality of the elastic connection terminals to the flexible circuit board to form at least one connection terminal group of the flexible circuit board.

[0013] Preferably, the steps of preparing a flexible circuit board specifically include: preparing a flexible circuit board, the flexible circuit board including at least two flexible boards, and forming at least one gap between two of the at least two flexible boards, wherein a contact is provided in the gap; inserting a separation tool into the gap, so that the gap expands into a plug-in space; removing the separation tool after the plug-in space is formed, wherein each plug-in space constitutes a connection terminal group.

[0014] Preferably, the steps of fabricating the flexible circuit board specifically include: fabricating a first quick connector, the first quick connector comprising: a first connector body, a top bead, and a first elastic member; the first connector body having a first receiving cavity extending along a first direction and a first insertion cavity penetrating the first connector body along a second direction, the first receiving cavity communicating with the first insertion cavity; the top bead being disposed at a position in the first receiving cavity communicating with the first insertion cavity, and a portion of the top bead being able to extend into the first insertion cavity; the first elastic member being disposed within the first receiving cavity and providing elastic support force to the top bead; and welding a plurality of the first quick connectors to the flexible circuit board to form at least one connection terminal group of the flexible circuit board.

[0015] Preferably, the steps for fabricating the flexible circuit board specifically include: fabricating a second quick connector, the second quick connector comprising: a second connector body and a second elastic member, the second connector body having a second insertion cavity penetrating through a first surface and a second surface, a second receiving cavity communicating with the second insertion cavity, and support holes located on two opposite sidewalls of the second receiving cavity; the second elastic member comprising an integrally formed arcuate plate and insertion plates disposed on both sides of the arcuate plate, the arcuate plate being disposed within the second receiving cavity and a portion of the arcuate plate being able to extend into the second insertion cavity, each insertion plate being disposed within a corresponding support hole; and welding multiple second quick connectors to the flexible circuit board to form at least one connection terminal group of the flexible circuit board.

[0016] Preferably, after the step of inserting the proximal end of the electrode body into the corresponding connection terminal group of the flexible circuit board, the method of manufacturing the implantation device further includes: fixing the electrode body onto the flexible circuit board using an electrode holder.

[0017] According to a second aspect of the present invention, an implantation device is provided, comprising: a flexible circuit board having at least one set of connecting terminals; and at least one electrode body, each of the at least one electrode body having a tail electrode ring set at its proximal end and a head electrode ring set at its distal end; wherein the proximal end of the electrode body is capable of being inserted into a corresponding set of connecting terminals of the flexible circuit board, such that the tail electrode ring set at the proximal end is electrically connected to the corresponding set of connecting terminals.

[0018] Preferably, each of the at least one electrode body comprises: a first tube and a second tube, the first tube and the second tube being connected by 2n wires, the 2n wires passing through 2n peripheral cavities of the first tube and the second tube respectively and surrounding the central cavity of the first tube and the second tube; a packing tube, the packing tube being located between the first tube and the second tube, and the axial position of the packing tube being aligned with the axial position of the first tube and the second tube; 2n wires, the 2n wires surrounding the packing tube; and a single-cavity tube, the single-cavity tube enclosing the end of the first tube near the packing tube, the 2n wires between the first tube and the second tube, the packing tube, and the end of the second tube near the packing tube; the first tube, the packing tube, the second tube, and the single-cavity tube are integrally formed.

[0019] Preferably, the first tube and the second tube each contain 2n+1 cavities extending along the axial direction of the tube, one of which is a central cavity located at the axis of the tube, and the remaining 2n peripheral cavities are distributed around the central cavity, where n is an integer greater than or equal to 1 and less than or equal to 8, and the 2n wires are respectively inserted into the 2n peripheral cavities of the first tube and the second tube.

[0020] Preferably, the first tube and the second tube each include: 2n slits formed on the outer wall of the tube in a predetermined order and at predetermined intervals along the axial and circumferential directions, each slit exposing an outer peripheral cavity; 2n wires inserted into the 2n outer peripheral cavities of the first and second tubes respectively and each having an exposed end passing through the slits on the outer peripheral cavity; and 2n electrode rings sequentially spaced on the outer wall of the tube and covering the 2n slits respectively, thereby electrically connecting to the exposed ends of the 2n wires respectively; wherein, the 2n electrode rings located on the first tube are head electrode rings and form a head electrode ring group at the distal end, and the 2n electrode rings located on the second tube are tail electrode rings and form a tail electrode ring group at the proximal end.

[0021] Preferably, the wire is electrically connected to the corresponding electrode ring through a riveting component; wherein the riveting component is a metal ring riveted into an arc shape, the curved surface of the metal ring is consistent with the inner surface of the electrode ring and is welded to the inner surface of the electrode ring.

[0022] Preferably, each of the at least one connection terminal group includes a plurality of resilient connection terminals, each resilient connection terminal including: a bracket; and two resilient arc plates disposed at the top of the bracket, the two resilient arc plates being recessed in a direction away from each other to form a clamping space, and the two resilient arc plates being able to provide clamping force to the electrode body inserted into the clamping space.

[0023] Preferably, the flexible circuit board is formed by laminating at least two flexible boards. The flexible circuit board is divided into a first board and a second board. The flexible circuit board is provided with: at least one spacer groove extending along a first direction and disposed between the first board and the second board; at least one boss disposed on a first side of the first board at a position corresponding to the spacer groove; and at least one insertion space disposed between two of the at least two flexible boards. The insertion space penetrates the first board and the boss along a second direction and communicates with the corresponding spacer groove. The insertion space is provided with a contact that can be electrically connected to an electrode body to be inserted.

[0024] Preferably, each of at least one connection terminal group includes a plurality of first quick connectors, each first quick connector including: a first connector body having a first receiving cavity extending in a first direction and a first insertion cavity penetrating the first connector body in a second direction, the first receiving cavity communicating with the first insertion cavity; a top bead disposed in the first receiving cavity at a position communicating with the first insertion cavity, and a portion of the top bead being capable of extending into the first insertion cavity; and a first elastic member disposed in the first receiving cavity and providing elastic support force to the top bead.

[0025] Preferably, each of at least one connection terminal group includes a plurality of second quick connectors, each second quick connector including: a second connector body having a second insertion cavity penetrating a first surface and a second surface of the second connector body, a second receiving cavity communicating with the second insertion cavity, and support holes located on two opposite sidewalls of the second receiving cavity; and a second elastic member including an integrally formed arcuate plate and insertion plates disposed on both sides of the arcuate plate, the arcuate plate being disposed within the second receiving cavity and a portion of the arcuate plate being able to extend into the second insertion cavity, each insertion plate being disposed within a corresponding support hole.

[0026] Preferably, the implantation device further includes: an electrode holder, which is mounted to the flexible circuit board and used to fix the electrode body on the flexible circuit board.

[0027] The implantation device of the present invention separates the electrode body and the flexible circuit board. The user can directly insert the electrode body into the connection terminal group of the circuit board by hand to achieve electrical connection. This method is reliable, low cost, simple to manufacture, and can be installed and removed relatively easily.

[0028] The methods and apparatus of the present invention have other features and advantages that will be apparent from or will be set forth in detail in the accompanying drawings and subsequent embodiments incorporated herein, which together serve to explain the particular principles of the invention. Attached Figure Description

[0029] Figure 1 A schematic diagram of the implantation device provided for an embodiment of the present invention;

[0030] Figure 2 A schematic diagram of the electrode body provided for an embodiment of the present invention;

[0031] Figure 3 A partial perspective view of the tube and wire according to the present invention is shown;

[0032] Figure 4 A partial perspective view of the tube body, packing tube, and wire according to an embodiment of the present invention is shown;

[0033] Figure 5 A cross-sectional schematic diagram of the packing tube and the wire according to an embodiment of the present invention is shown;

[0034] Figure 6 A partial perspective view of a tube body according to an embodiment of the present invention is shown;

[0035] Figure 7 A partial perspective view of the tube body and the protruding end of the wire according to an embodiment of the present invention is shown;

[0036] Figure 8 A perspective view of a wire and a metal ring according to an embodiment of the present invention is shown;

[0037] Figure 9 A perspective view of the wire and the riveted metal ring according to an embodiment of the present invention is shown;

[0038] Figure 10 An enlarged perspective view of the wire and the riveted metal ring according to an embodiment of the present invention is shown;

[0039] Figure 11 A perspective view of the wire, the riveted metal ring, and the electrode ring according to an embodiment of the present invention is shown;

[0040] Figure 12 A partial perspective view of the mandrel, packing tube, and wire according to an embodiment of the present invention is shown;

[0041] Figure 13 A partial perspective view of the mandrel, packing tube, wire, and single-lumen tube according to an embodiment of the present invention is shown;

[0042] Figure 14 An overall view of the electrode body according to an embodiment of the present invention is shown;

[0043] Figure 15 This is a schematic diagram of the structure of the elastic connection terminal according to an embodiment of the present invention;

[0044] Figure 16 for Figure 15 The main view;

[0045] Figure 17 for Figure 16 Sectional view at point AA;

[0046] Figure 18 This is a schematic diagram of the insertion of the elastic connection terminal and the electrode body in an embodiment of the present invention;

[0047] Figure 19 for Figure 18 A schematic diagram showing the fit between the middle electrode ring and the elastic connection terminal;

[0048] Figure 20 This is a schematic diagram of the structure of the first quick-connect seat according to an embodiment of the present invention;

[0049] Figure 21 for Figure 20 A sectional view;

[0050] Figure 22 This is a schematic diagram of the internal structure of the first connecting seat body;

[0051] Figure 23 This is a schematic diagram showing the insertion of the first quick connector into the electrode body;

[0052] Figure 24 for Figure 23 A schematic diagram of the engagement between the middle electrode ring and the first quick-connect seat;

[0053] Figure 25 This is a schematic diagram of the structure of the second quick-connect seat according to an embodiment of the present invention;

[0054] Figure 26 for Figure 25 A sectional view;

[0055] Figure 27 for Figure 26 A diagram from another perspective;

[0056] Figure 28 This is a schematic diagram of the structure of the second connecting seat body;

[0057] Figure 29 for Figure 28 A sectional view;

[0058] Figure 30 for Figure 29 A diagram from another perspective;

[0059] Figure 31 This is a schematic diagram of the structure of the second elastic member;

[0060] Figure 32This is a schematic diagram showing the insertion of the first quick connector into the electrode body;

[0061] Figure 33 for Figure 32 A schematic diagram showing the fit between the middle electrode ring and the second quick-connect seat;

[0062] Figure 34 A schematic diagram of the structure of a flexible circuit board according to an embodiment of the present invention. Figure 1 ;

[0063] Figure 35 This is a schematic diagram illustrating the composition of a flexible circuit board according to an embodiment of the present invention;

[0064] Figure 36 A schematic diagram of the structure of a flexible circuit board according to an embodiment of the present invention. Figure 2 ;

[0065] Figure 37 for Figure 36 A schematic diagram of the combination of the flexible circuit board and the electrode holder;

[0066] Figure 38 for Figure 37 A schematic diagram of the connection between the flexible circuit board and the electrode body;

[0067] Figure 39 Schematic diagram of the location of the spacer slot Figure 1 ;

[0068] Figure 40 Schematic diagram of the location of the spacer slot Figure 2 ;

[0069] Figure 41 Schematic diagram of the location of the spacer slot Figure 3 ;

[0070] Figure 42 Schematic diagram of the location of the spacer slot Figure 4 ;

[0071] Figure 43 This is a schematic diagram of the structure of an electrode holder;

[0072] Figure 44 for Figure 43 A schematic diagram of the electrode holder mechanism from another perspective;

[0073] Figure 45 This is a schematic diagram of the combination of a flexible circuit board and a protective layer;

[0074] Figure 46 for Figure 45 3D exploded view;

[0075] Figure 47 This is a schematic diagram showing the fit between the flexible circuit board and the electrode holder;

[0076] Figure 48 This is a schematic diagram showing one slot corresponding to two gaps;

[0077] Figure 49 This is a schematic flowchart of a method for manufacturing an implantable device according to an embodiment of the present invention;

[0078] Figure 50 This is a schematic diagram of the process for preparing at least one electrode body according to an embodiment of the present invention;

[0079] Figure 51 for Figure 50 A flowchart illustrating step b1 in the middle section;

[0080] Figure 52 for Figure 51 A flowchart illustrating step b14 in the middle section;

[0081] Figure 53 for Figure 50 A flowchart illustrating step b4 in the middle section;

[0082] Figure 54 for Figure 49 A flowchart illustrating step a.

[0083] It should be understood that the accompanying drawings are not necessarily drawn to scale, but rather present simplified representations of various features to illustrate the basic principles of the invention. Specific design features disclosed in this invention (including, for example, specific dimensions, orientations, positions, and shapes) will be determined in part by the specific environment in which they are intended for application and use.

[0084] Throughout these figures, the same reference numerals denote the same or equivalent parts of the invention. Detailed Implementation

[0085] Reference will now be made in detail to various embodiments of the invention, examples of which are presented in the accompanying drawings and described below. Although the invention will be described in conjunction with exemplary embodiments, it should be understood that this specification is not intended to limit the invention to these exemplary embodiments. Rather, the invention is intended to cover not only these exemplary embodiments, but also various alternatives, modifications, equivalents, and other embodiments that may be included within the spirit of the invention and the scope defined by the appended claims.

[0086] The following is combined Figures 1 to 54 A method for manufacturing an implantable device according to an embodiment of the present invention will be described.

[0087] First, in order to more clearly describe the embodiments of the present invention, the terms "proximal end" and "distal end" need to be defined.

[0088] When a physician is performing a routine procedure with a tool or instrument (such as forceps) in front of a patient, and the tool or instrument (such as forceps) is positioned between the physician and the patient, the end closer to the physician is called the "proximal end," and the end farther from the physician (the end closer to the patient) is called the "distal end." In other words, for example, when a physician holds a syringe to give an injection to a patient, the tail end of the syringe (the part where the physician presses with their thumb) can be called the "proximal end," and the needle tip can be called the "distal end."

[0089] Furthermore, "head electrode rings" refer to all electrode rings closer to the patient relative to the packing tube, while "tail electrode rings" refer to all electrode rings closer to the physician relative to the packing tube. Therefore, if the first tube is closer to the patient relative to the packing tube and the second tube is closer to the physician relative to the packing tube, then "head electrode rings" refer to all electrode rings on the first tube, and "tail electrode rings" refer to all electrode rings on the second tube. Following the direction from the patient towards the physician, the "head electrode rings" are sequentially designated as the first head electrode ring, the second head electrode ring, ..., and the 2nth head electrode ring; similarly, following the direction from the patient towards the physician, the "tail electrode rings" are sequentially designated as the first tail electrode ring, the second tail electrode ring, ..., and the 2nth tail electrode ring.

[0090] The above definitions of "proximal end" and "distal end", as well as "head electrode ring" and "tail electrode ring" are only for the convenience of describing the embodiments of the present invention, and do not limit the structure of the present invention.

[0091] The term "axial direction" refers to a direction that is substantially parallel to the axis of the pipe body.

[0092] The term "circumferential direction" refers to a direction that is essentially perpendicular to both the axial direction and the radius of the tube's cross-section, i.e., the circumferential direction around the tube's axis.

[0093] like Figure 49 As shown, the method for manufacturing an implantable device according to an embodiment of the present invention includes:

[0094] Step a: Prepare a flexible circuit board 1000, on which at least one connection terminal group 1100 is provided.

[0095] Step b, prepare at least one electrode body 9000, each of the at least one electrode body 9000 having a tail end electrode ring group 9001 at its proximal end and a head end electrode ring group 9002 at its distal end.

[0096] Step c: Insert the proximal end of the electrode body 9000 into the corresponding connection terminal group 1100 of the flexible circuit board 1000 so that the tail electrode ring group 9001 of the proximal end is electrically connected to the corresponding connection terminal group 1100.

[0097] The head electrode ring assembly 9002 on the electrode body 9000 can be implanted into the epidural space within the spinal canal, and the flexible circuit board 1000 is implanted subcutaneously in areas such as the back, buttocks, or lower abdomen through a subcutaneous tunnel.

[0098] This invention separates the electrode body 9000 and the flexible circuit board 1000. The user can directly insert the electrode body 9000 into the connection terminal group 1100 of the circuit board by hand to achieve electrical connection. This method of connection is reliable, low cost, simple to manufacture, and can be installed and disassembled relatively easily.

[0099] The user adjusts the parameters of the flexible circuit board 1000 through an external programmable device. The flexible circuit board 1000 can wirelessly receive radio frequency signals and energy from the programmable device to generate adjustable electrical pulses. The electrical pulses are transmitted to the spinal cord through the head electrode ring group 9002 of the electrode body 9000 to stimulate the spinal cord, thereby treating the patient, reducing the patient's pain, and improving the quality of life.

[0100] In an exemplary embodiment, prior to inserting the proximal end of the electrode body 9000 into the corresponding connection terminal group 1100 of the flexible circuit board 1000 (i.e., step c), the above-described method of manufacturing the implantation device further includes:

[0101] Electrode holders 5200 are mounted on the flexible circuit board 1000. The number of electrode holders 5200 corresponds to the number of connection terminal groups 1100. The proximal end of each electrode body 9000 can pass through a corresponding electrode holder and a corresponding connection terminal group 1100. After the electrode body 9000 is inserted into the connection terminal group 1100, the operator can lock the electrode body 9000 with the electrode holder to prevent it from detaching from the flexible circuit board 1000. In addition, the electrode holders 5200 are electrically connected to the flexible circuit board 1000, and can also be electrically connected to the tail electrode ring on the electrode body 9000.

[0102] In an exemplary implementation, such as Figure 50 As shown, the step of preparing at least one electrode (i.e., step b) specifically includes:

[0103] b1) A packing tube 9300 is inserted between the first tube 9100 and the second tube 9200. The first tube 9100 and the second tube 9200 are connected by 2n wires. The 2n wires pass through the 2n outer lumens of the first tube 9100 and the second tube 9200 respectively and surround the central lumen of the first tube 9100 and the second tube 9200, so that the 2n wires surround the packing tube 9300 and the axis of the packing tube 9300 is aligned with the axis of the first tube 9100 and the axis of the second tube 9200. Figure 3 As shown, the first tube 9100 and the second tube 9200 have the same structure, and the eight wires contained therein pass through eight corresponding outer peripheral cavities of the first tube 9100 and the second tube 9200, respectively. These eight wires (such as the first wire 9111, the second wire 9112, the third wire 9113, etc.) extend along the axial direction of the tube and are distributed around the axial center of the first tube 9100 and the second tube 9200. Figure 4 As shown, the inserted packing tube 9300 is located in the first tube body 9100 and the second tube body 9200 (not in...). Figure 4 As shown in the diagram, eight wires encircle the filler tube 9300, and the axis of the filler tube 9300 is aligned with the axis of the first tube 9100 and the axis of the second tube 9200 (i.e., the central lumen). The first tube 9100 and the second tube 9200 can be made of medical-grade materials such as thermoplastic polyurethane (TPU) or thermoplastic elastomer (TPE). These tubes are manufactured using special molds and are formed through heating and stretching. Therefore, these tubes possess good thermoplasticity and elasticity.

[0104] The outer diameter of the first tube 9100 and the second tube 9200 is 1 mm to 3 mm, preferably 1.1 mm to 2.5 mm.

[0105] The inner diameter of the central cavity 9120 of the first tube 9100 and the second tube 9200 is 0.3 mm to 0.7 mm, preferably 0.4 mm to 0.6 mm.

[0106] The inner diameters of the outer peripheral cavities 101, 102, 103, etc. of the first tube body 9100 and the second tube body 9200 are 0.1 mm to 0.3 mm.

[0107] The outer contour of the inserted stuffing tube 9300 cross-section is polygonal, therefore, each face of the polygonal stuffing tube can preferably be used to uniformly separate the wires. For example... Figure 5 As shown, the cross-section of the packing tube 9300 is square. Two wires are placed on each side of the cross-section of the packing tube 9300. For example, the first wire 9111 and the second wire 9112 are placed on the top side of the cross-section of the packing tube 9300 (see attached diagram). Figure 5This arrangement ensures that the eight wires are spaced apart in pairs. This placement of the wires and the 9300 filler tube prevents the wires from crossing and intertwining during the manufacturing process and after the product is finished.

[0108] The packing tube 9300 is made of medical-grade thermoplastic polyurethane material by stretching it using a special mold during heating. When the cross-section of the packing tube 9300 is square, the side length is 0.6 mm to 5 mm and the inner diameter is 0.3 mm to 4.5 mm, preferably 0.8 mm to 4.5 mm and the inner diameter is 0.5 mm to 4.0 mm.

[0109] like Figure 51 As shown, step b1 above can be divided into the following steps:

[0110] b11) Provides a first tube body 9100 and a second tube body 9200, each containing 2n+1 cavities extending along the axial direction of the tube body. One central cavity 9120 is located at the axis of the tube body, and the remaining 2n peripheral cavities are distributed around the central cavity 9120, where n is an integer greater than or equal to 1 and less than or equal to 8. For example... Figure 3 and 4 As shown, the first tube 9100 and the second tube 9200 each contain nine cavities extending along the axial direction of the tube. One central cavity 9120 is located at the axial center of both the first tube 9100 and the second tube 9200. The remaining eight peripheral cavities (such as the first peripheral cavity 9121, the second peripheral cavity 9122, the third peripheral cavity 9123, etc.) are distributed around the central cavity 9120. The peripheral cavities with the same number in both the first tube 9100 and the second tube 9200 are axially opposite each other and contain the same conductor. For example, the first peripheral cavity 9121 of the first tube 9100 and the first peripheral cavity 9200 (not shown in the figure) are axially opposite each other and contain the same first conductor 9111.

[0111] b12) On the outer walls of the first tube 9100 and the second tube 9200, 2n cuts are made along the axial and circumferential directions of the tubes in a predetermined cutting sequence and at predetermined cutting intervals, respectively, with each cut exposing at least one peripheral lumen. For example Figure 6 As shown, eight cuts are made on the outer wall of the first tube 9100 along the axial and circumferential directions of the first tube 9100 in a predetermined cutting sequence and at predetermined cutting intervals. Figure 6(Only three are shown in the image), such as the first cut 9131, the second cut 9132, and the third cut 9133 starting from the distal end. Each cut exposes at least one peripheral lumen, and the eight cuts expose at least eight corresponding peripheral lumens. This step can be performed on a specially designed rotary pipe cutting fixture. In this step, after each cut, the pipe is rotated at a predetermined angle in the circumferential direction and displaced in the axial direction before the next cut, so that adjacent cuts are offset from each other in both the circumferential and axial directions.

[0112] Preferably, the angle difference between the (m+1)th cut and the mth cut in the circumferential direction of the tube is . Where m is an integer greater than or equal to 1 and less than 2n, positive values ​​indicate clockwise and negative values ​​indicate counterclockwise. The predetermined axial cutting sequence in this step is from one end of the tube to the other. For example, from the distal end to the proximal end of the first tube 9100. The distance between the (m+1)th cut and the mth cut in the axial direction of the tube is 0.5 mm to 20 mm, preferably 1 mm to 18 mm. In this step, each cut is made such that each cut exposes at least one peripheral lumen, but not the central lumen.

[0113] When making cuts in the second tube 9200, the axial sequence of the cuts is the same as that of the first tube 9100. For example, if the first tube 9100 is cut from its distal end to obtain a first cut 9131, a second cut 9132, and a third cut 9133, then the second tube 9200 is also cut from its distal end to obtain a first cut, a second cut, and a third cut (not shown in the figures). The circumferential cuts in the second tube 9200 are also consistent with the circumferential cuts in the first tube 9100. That is, preferably, the angle difference between the (m+1)th cut and the mth cut on the second tube 9200 in the circumferential direction is... The distance between the (m+1)th cut and the mth cut in the axial direction of the tube is 0.5 mm to 20 mm, preferably 1 mm to 18 mm. In this step, each cut is made such that each cut exposes at least one peripheral lumen, but the central lumen must not be exposed.

[0114] The cuts made to the first pipe body 9100 and the second pipe body 9200 can be made simultaneously or separately, and can be completed on the same or different specially designed rotary pipe cutting fixtures. Preferably, the cuts made to the first pipe body 9100 and the second pipe body 9200 are made alternately on the same specially designed rotary pipe cutting fixture to maintain the stability and similarity of the position and depth of the cuts on the first pipe body 9100 and the second pipe body 9200.

[0115] (b13) Insert 2n wires into the 2n outer cavities of the first tube 9100 and the second tube 9200, respectively. For example... Figure 3 As shown, a first lead 9111 is inserted into the first peripheral lumen 9121 of the corresponding first tube 9100 and the first peripheral lumen of the second tube 9200 (not shown in the figure). The lead can be made of a medical-grade, NMR-compatible, and low-resistance metallic material, such as platinum-iridium alloy, MP35N, silver alloy, etc. Each lead has a diameter of 0.1 mm to 1 mm and a length of 10 cm to 100 cm, preferably a diameter of 0.12 mm to 0.88 mm and a length of 12 cm to 95 cm.

[0116] (b14) Take one end of 2n wires from the 2n cuts on the outer wall of the first tube 9100 and pull them out of the tube in a predetermined order, and connect them to the 2n head electrode rings respectively. Take the other end of 2n wires from the 2n cuts on the outer wall of the second tube 9200 and pull them out of the tube in a predetermined order, and connect them to the 2n tail electrode rings respectively. The 2n tail electrode rings form the tail electrode ring group of the proximal end, and the 2n head electrode rings form the head electrode ring group of the distal end.

[0117] Step b14) can be divided into the following steps:

[0118] (b141) Starting from the first incision 9131 furthest from the first tube body 9100, one end of the first wire 9111 in the first peripheral lumen 9121 is removed. For example... Figure 7 As shown, starting from the first cut 9131 furthest from the first end of the first tube body 9100, the protruding end 9141 of the first wire 9111 in the first peripheral cavity 9121 of the first tube body 9100 is picked out.

[0119] (b142) A first end electrode ring is fitted onto the distal end of the first tube 9100, so that the first end electrode ring surrounds the first tube 9100 and covers the first cut 9131, and is electrically connected to the protruding end of the first wire 9111. The electrical connection between the electrode ring and the wire further includes the following steps: riveting a metal ring 9151 to the protruding end of the wire, wherein the riveted metal ring 9151 is arc-shaped and its curved surface is consistent with the inner surface of the electrode ring; welding the metal ring 9151 to the inner surface of the electrode ring.

[0120] For example Figures 8 to 11As shown, a first electrode ring 9161 is fitted onto the distal end of the first tube 9100, so that the first electrode ring 9161 surrounds the first tube 9100 and covers the first cut 9131, and is electrically connected to the protruding end 9141 of the first wire 9111. Preferably, the inner diameter of the first electrode ring 9161 is slightly larger than the diameter of the first tube 9100. To facilitate the electrical connection between the protruding end 9141 of the first wire 9111 and the first electrode ring 9161, those skilled in the art can adjust the length of the protruding wire as needed. This step can be divided into the following steps.

[0121] b142a) as Figure 8 As shown, firstly, a metal ring 9151 is fitted onto the protruding end 9141 of the first wire 9111 in the first outer peripheral cavity 9121, and then the metal ring 9151 is riveted. The outer diameter of the metal ring 9151 is 0.5 mm to 3 mm, the wall thickness is 0.01 mm to 1 mm, and the length is 0.5 mm to 10 mm; preferably, the outer diameter is 0.8 mm to 2.5 mm, the wall thickness is 0.1 mm to 0.8 mm, and the length is 0.8 mm to 8 mm. Figure 9 As shown, the riveted metal ring 9151 is arc-shaped, and its curved surface matches the inner surface of the first electrode ring 9161. The metal ring 9151 is made of a medical-grade, NMR-compatible metal material, such as a platinum-iridium alloy or a titanium alloy, and is machined to specific dimensions. In some embodiments, the riveted metal ring 9151 can also be other shapes that increase the surface area of ​​the welding point between the wire and the electrode ring. In other embodiments, other metal materials that increase the surface area of ​​the welding point between the wire and the electrode ring can be used, or the metal ring can be riveted into other shapes that increase the surface area of ​​the welding point between the wire and the electrode ring. For example, small metal sheets of various shapes can be introduced.

[0122] b142b) as Figure 10 and Figure 11 As shown, the first electrode ring 9161 is then fitted onto the first tube 9100 from its distal end, covering the first cut 9131. The riveted metal ring 9151 is then welded to the inner surface of the first electrode ring 9161, thus completing the electrical connection between the first wire 9111 and the first electrode ring 9161. The welding method for this step can be selected from soldering, resistance welding, and laser welding.

[0123] (b143) Repeat steps b141) and b142) until the 2n-end electrode ring covers the 2n-end cut of the first tube 9100 and is electrically connected to the protruding end of the 2n-end wire. For example, repeat steps b141) and b142) until the 8th electrode ring of the first tube 9100 covers the 8th cut of the first tube 9100 from the proximal end to the distal end and is electrically connected to the protruding end of the 8th end wire.

[0124] (b144) Starting from the first incision closest to the distal end of the second tube body 9200, pick out the other end of the first wire in the first peripheral lumen. For example, starting from the first incision closest to the distal end of the second tube body 9200, pick out the other end of the first wire 9111 in the first peripheral lumen.

[0125] (b145) A first tail electrode ring is fitted onto the proximal end of the second tube 9200, so that the first tail electrode ring wraps around the second tube 9200 and covers the first cut, and is electrically connected to the other protruding end of the first wire 9111. For example, the first tail electrode ring is fitted onto the proximal end of the second tube 9200, so that the first tail electrode ring wraps around the second tube 9200 and covers the first cut, and is electrically connected to the other protruding end of the first wire 9111.

[0126] (b146) Repeat steps b144) and b145) until the 2n tail electrode ring covers the 2n cut of the second tube 9200 and is electrically connected to the other end of the 2n wire. For example, repeat steps b144) and b145) until the 8th tail electrode ring covers the 8th cut of the second tube 9200 from the distal end to the proximal end and is electrically connected to the other end of the 8th wire. In some embodiments, steps b144), b145) and b146) are the same steps as steps b141), b142) and b143) performed at corresponding positions on the second tube 9200, so the parts that are the same as steps b141), b142) and b143) will not be described again here.

[0127] For the first tube 9100, for each wire picked out, a corresponding electrode ring must be soldered. The soldered electrode ring is put into the first tube 9100 from the far end (i.e. the end away from the second tube 9200). If the wire closest to the far end of the first tube 9100 is picked out first, after the corresponding electrode ring is soldered, the electrode ring will prevent the electrode ring corresponding to the wire closer to the proximal end from being put into the first tube 9100 from the far end (i.e. the end away from the second tube 9200).

[0128] The above-mentioned process principle also applies to the second tube 9200, so the first tube 9100 and the second tube 9200 should both start picking the wire from the end closest to each other (i.e., from the proximal end of the first tube 9100 and the distal end of the second tube 9200).

[0129] b2) Insert the mandrel 9400 through the central cavity of the first tube 9100, the packing tube 9300, and the central cavity of the second tube 9200 so that the first tube 9100, the packing tube 9300, and the second tube 9200 come into contact in sequence. For example Figure 12As shown, a mandrel 9400 is inserted through the central cavity 9120 of the first tube 9100, the packing tube 9300, and the central cavity of the second tube 9200, so that the first tube 9100, the packing tube 9300, and the second tube 9200 come into contact in sequence. Because the mandrel 9400 serves to support and retain the central cavities 9120 of the first tube 9100 and the second tube 9200, the diameter of the mandrel 9400 is less than or equal to the diameter of the central cavity 9120.

[0130] Preferably, those skilled in the art can select a diameter for the mandrel 9400 that facilitates insertion into the central cavity 9120 and is sufficient to support the first tube 9100 and the second tube 9200. Since the mandrel 9400 is cylindrical, the packing tube 9300 may undergo slight deformation after insertion. The mandrel 9400 is made of stainless steel and its surface is coated with polytetrafluoroethylene (PTFE). The PTFE coating prevents the mandrel 9400 from sticking to the central cavities 9120 of the first tube 9100 and 9200 of the second tube during heat shrinkage, thus facilitating subsequent removal of the mandrel 9400.

[0131] b3) Wrap the end of the first tube 9100 near the packing tube 9300, the 2n wires between the first tube 9100 and the second tube 9200, and the packing tube 9300, as well as the end of the second tube 9200 near the packing tube 9300, with a single-lumen tube 9500. For example Figure 13 As shown, a single-lumen tube 9500 encloses the end of the first tube body 9100 near the packing tube 9300, eight wires between the first tube body 9100 and the second tube body 9200, the packing tube 9300, and the end of the second tube body 9200 near the packing tube 9300 (not shown in the figure). The single-lumen tube 9500 is made of medical-grade thermoplastic polyurethane material by stretching it using a special mold during heating. The outer diameter of the single-lumen tube 9500 is 1.0 mm to 5.5 mm, and the wall thickness is 0.1 mm to 2 mm, preferably 1.2 mm to 5.0 mm, and the wall thickness is 0.15 mm to 1.95 mm.

[0132] b4) Connect the first tube body 9100, the packing tube 9300, the second tube body 9200, and the single-lumen tube 9500 to each other. This step can be divided into the following steps:

[0133] (b41) Heat shrink tubing is applied to the outside of the first tube 9100, the single-lumen tube 9500, and the second tube 9200 and then heated. In this step, the heat shrink tubing covers all structures, namely: the eight electrode rings on each of the first tube 9100 and the second tube 9200, the outer walls of the first tube 9100 and the second tube 9200 not covered by the electrode rings, and the single-lumen tube 9500. The size of the heat shrink tubing is selected such that its inner diameter is larger than the outer diameter of the electrode rings, the tube, and the single-lumen tube, and the material of the heat shrink tubing is selected such that its heat shrinking temperature is greater than the melting point of the materials of the tube, the filler tube, and the single-lumen tube. The heat shrink tubing is heated to a temperature greater than or equal to its heat shrinking temperature, causing the heat shrink tubing to shrink and the materials of the tube, the filler tube, and the single-lumen tube to melt, so that the diameter of all the outer lumens of the first tube 9100 and the second tube 9200 is reduced to the same as the outer diameter of each wire, so as to achieve the effect of all the outer lumens tightly wrapping their respective wires. Similarly, in the single-lumen tube wrapping section, the molten single-lumen tube and filler tube fill the gaps between the eight wires, achieving a tight wrapping effect for all wires. The gaps between the eight head electrode rings and the outer wall of the first tube body 9100, and between the eight tail electrode rings and the outer wall of the second tube body 9200, are also filled with molten tube material, achieving a tight fit between the eight head electrode rings and the first tube body 9100, and between the eight tail electrode rings and the outer wall of the second tube body 9200. The gap between the central lumen 9120 and the mandrel 9400 is also filled with the heat-shrinkable tube material. The first tube body 9100, the second tube body 9200, and the single-lumen tube 9500 between them are also fused together due to the compression and filling of the above structure. The heat-shrinkable tubing is made of perfluoroethylene-propylene copolymer. The heat shrink tubing has an outer diameter of 1 mm to 5 mm and a wall thickness of 0.1 mm to 2 mm, preferably an outer diameter of 1.2 mm to 4.5 mm and a wall thickness of 0.2 mm to 1.8 mm.

[0134] (b42) Peel off the heat shrink tubing and remove the mandrel 9400. After cooling the first tube body 9100, the eight head electrode rings on the first tube body 9100, the second tube body 9200, the eight tail electrode rings on the second tube body 9200, the single-lumen tube, and the heat shrink tubing to fix the shape of the overall structure, the heat shrink tubing can be peeled off and the mandrel 9400 removed. At this time, the central cavity 9120 of the first tube body 9100 and the central cavity of the second tube body 9200 are hollow cavities, and their shapes are maintained by the presence of the mandrel 9400 during the heat shrinking process. Due to the presence of the mandrel 9400 and the heat shrinking process, the interior of the filler tube 9300 also forms a hollow shape corresponding to the central cavity 9120 of the first tube body 9100 and the central cavity of the second tube body 9200.

[0135] Preferably, after step b42), the distal end of the first tube 9100 needs to be sealed. In this step, the distal end of the first tube 9100 is thermally softened and cooled to seal the distal end.

[0136] In an exemplary embodiment, the step of fabricating the flexible circuit board (i.e., step a) specifically includes:

[0137] An elastic connection terminal 2100 is prepared. The elastic connection terminal 2100 includes a support 2110 and two elastic arc plates 2120. The two elastic arc plates 2120 are disposed at the top of the support 2110. The two elastic arc plates 2120 are recessed in a direction away from each other to form a clamping space 2121. The two elastic arc plates 2120 can provide clamping force to the electrode body 9000 inserted into the clamping space 2121.

[0138] Multiple flexible connection terminals 2100 are soldered to the flexible circuit board 1000 to form at least one connection terminal group 1100 of the flexible circuit board 1000 (see also [reference]). Figures 15 to 19 ).

[0139] Specifically, two sets of connection terminal groups are soldered onto the flexible circuit board 1000, each set of connection terminal groups including 8 flexible connection terminals 2100.

[0140] In an exemplary embodiment, the step of fabricating the flexible circuit board (i.e., step a) specifically includes:

[0141] A first quick connector 3100 is prepared, comprising: a first connector body 3110, a top bead 3120, and a first elastic member 3130. The first connector body 3110 is provided with a first receiving cavity 3111 extending along a first direction and a first insertion cavity 3112 penetrating the first connector body 3110 along a second direction, the first receiving cavity 3111 communicating with the first insertion cavity 3112; the top bead 3120 is disposed at a position in the first receiving cavity 3111 communicating with the first insertion cavity 3112, and a portion of the top bead 3120 can extend into the first insertion cavity 3112; the first elastic member 3130 is disposed in the first receiving cavity 3111 and provides elastic support force to the top bead 3120.

[0142] Multiple first quick connectors 3100 are soldered to the flexible circuit board 1000 to form at least one connection terminal group 1100 of the flexible circuit board 1000 (see also [reference]). Figures 20 to 24 ).

[0143] Specifically, the side surface 3118 of the first connecting seat body 3110 (see reference) Figure 20 ) Welded to the flexible circuit board 1000.

[0144] In an exemplary embodiment, the step of fabricating the flexible circuit board (i.e., step a) specifically includes:

[0145] A second quick connector 4100 is prepared. The second quick connector 4100 includes: a second connector body 4110 and a second elastic member 4130. The second connector body 4110 is provided with a second insertion cavity 4113 penetrating through a first surface 4111 and a second surface 4112 of the second connector body 4110, a second receiving cavity 4114 communicating with the second insertion cavity 4113, and support holes located on two opposite sidewalls 4115 and 4116 of the second receiving cavity 4114. The second elastic member 4130 includes an integrally formed arc-shaped plate 4131 and insertion plates 4132 and 4133 disposed on both sides of the arc-shaped plate 4131. The arc-shaped plate 4131 is disposed in the second receiving cavity 4114 and a portion of the arc-shaped plate 4131 can extend into the second insertion cavity 4113. Each insertion plate 4132 and 4133 is disposed in a corresponding support hole.

[0146] Multiple second quick connectors 4100 are soldered to the flexible circuit board 1000 to form at least one connection terminal group 1100 of the flexible circuit board 1000 (see also [reference]). Figures 25 to 33 ).

[0147] Specifically, the third side 4119 or the fourth side 4120 of the second quick connector 4100 (see reference) Figure 25 ) Welded to the flexible circuit board 1000.

[0148] In an exemplary implementation, such as Figure 54 As shown, the steps for fabricating a flexible circuit board (i.e., step a) specifically include:

[0149] (a110) Fabrication of a flexible circuit board 1000, the flexible circuit board 1000 comprising at least two flexible layers, and at least one gap 5111 formed between two of the at least two flexible layers (see also [reference]). Figure 34 A contact point (not shown) is provided inside the gap 5111.

[0150] (a120) Insert the separating tool (not shown) into the gap 5111, so that the gap 5111 expands into the insertion space 112 (see fitting). Figure 36 ).

[0151] (a130) After forming the insertion space 112, remove the separation tool. Each insertion space constitutes a connection terminal group 1100 (see details). Figures 34 to 36 ).

[0152] Furthermore, step c specifically includes:

[0153] Insert electrode 9000 into insertion space 5112 (see also the following for details) Figure 38 And make the electrode body 9000 electrically connected to the contacts in the insertion space 5112.

[0154] This implementation scheme allows the electrode body 9000 to be inserted into the insertion space 5112, and makes the electrode body 9000 electrically connected to the contacts within the insertion space 5112. While ensuring the electrical connection, the following effects are achieved:

[0155] On the one hand, the thickness of the insertion space 5112 directly includes the thickness of the flexible circuit board 1000, reducing the overall thickness and thus reducing the difficulty of installation.

[0156] On the other hand, the insertion space 5112 can be used with the electrode fixing seat to directly lock the inserted electrode body 9000. The insertion space 5112 replaces the original flexible connection terminal, avoiding magnetization by the nuclear magnetic resonance equipment and preventing positional movement. The material of the two flexible plates forming the insertion space 5112 is not affected by the nuclear magnetic resonance equipment, further reducing costs.

[0157] In an exemplary implementation, such as Figure 35 As shown, the flexible circuit board 1000 includes four flexible boards, namely flexible board 5101, flexible board 5102, flexible board 5103 and flexible board 5104.

[0158] Among them, flexible plates 5101 and 5104 are substrates, and flexible plates 5102 and 5103 are copper layers.

[0159] In an exemplary implementation, such as Figure 34 As shown, there are two gaps 5111. The number of gaps 5111 can be adjusted according to the situation, for example, it can be set to any number from 1 to 4.

[0160] In an exemplary embodiment, the above-described steps for fabricating the flexible circuit board (i.e., step a110) specifically include:

[0161] (a101) At least two flexible boards are pressed together to form a flexible circuit board 1000, and a hollow area 5105 without adhesive is reserved between two of the flexible boards 5102 and 5103 (see also) Figure 35 To form a gap 5111, wherein at least one of the two flexible plates 5102, 5103 has a contact point pre-set at a position corresponding to the hollow region 5105.

[0162] Specifically, flexible plates 5102 and 5103 are in the hollow region 5105 (see also...). Figure 35 The corresponding position has multiple contacts, which can be electrically connected to the electrode body 9000 inserted into the insertion space 5112. After the flexible board is pressed, the uncoated part can be stretched open, and the other parts form an inseparable circuit board.

[0163] In an exemplary embodiment, before inserting the separating tool into the slot 5111, causing the slot 5111 to expand into the insertion space 5112 (i.e., step a120), the above-described step of preparing the flexible circuit board (i.e., step a110) further includes:

[0164] a111) on the flexible circuit board 1000 along the first direction (i.e. Figure 34 At least one spacer groove 5113 is prepared in the x-axis direction (see also the figure). Figure 34 ), to distinguish the first board 5106 and the second board 5107 (see also) Figure 34 ), wherein each gap 5111 is along the second direction (i.e. Figure 34 The y-axis direction extends through the first plate 5106 and connects to the corresponding spacer slot 5113.

[0165] The first plate 5106 and the second plate 5107 are integrated into one piece.

[0166] The number of slots 5113 and gaps 5111 can be adjusted as needed, for example, they can be set to any number from 1 to 4.

[0167] For example, the spacer slot 5113 can be set to one (see also...) Figure 40 It can also be set to two (see also: see below for details). Figure 39 ), or set to three (see also: Figure 41 ).

[0168] The number of slots 5113 can be equal to the number of gaps 5111, for example... Figure 42 In the middle, one slot 5113 corresponds to one gap 5111.

[0169] The number of slots 5113 can also be less than the number of gaps 5111, for example Figure 48 In this context, one slot 5113 can correspond to two gaps 5111.

[0170] exist Figure 42 and Figure 48 In the middle, the approximate location of gap 5111 is indicated by a dotted line.

[0171] Specifically, laser cutting, die stamping, and other processes can be used to cut the flexible circuit board 1000 along the first direction (i.e., Figure 34 Cut a spacer groove 5113 in the x-axis direction.

[0172] The sidewall of the spacer groove 5113 also serves to position the electrode body 9000. That is, when the electrode body 9000 is inserted into the spacer groove 5113, the sidewall of the spacer groove 5113 will press against the electrode body 9000, preventing the electrode body 9000 from moving along the second direction (i.e., ...). Figure 36 Continue inserting along the y-axis to position the electrode body 9000.

[0173] In an exemplary embodiment, before inserting the separating tool into the slot 5111, causing the slot 5111 to expand into the insertion space 5112 (i.e., step a120), the above-described step of preparing the flexible circuit board (i.e., step a110) further includes:

[0174] (a112) A boss 5109 is formed at a position corresponding to the spacer groove 5113 on the first side portion 5108 of the first plate 5106, and the gap 5111 passes through the boss 5109 (see mating details). Figure 34 ).

[0175] The number of bosses 5109, slots 5113 and gaps 5111 are equal and can be adjusted according to the situation. For example, they can be set to any number from 1 to 4.

[0176] Specifically, protrusions 5109 can be cut out on the flexible circuit board 1000 using processes such as laser cutting and die stamping.

[0177] The step of forming the boss 5109 (i.e., step a112) can be performed before or after the step of forming the spacer groove 5113 (i.e., step a111).

[0178] The steps of forming the boss 5109 (i.e., step a112) and forming the spacer groove 5113 (i.e., step a111) can also be completed in one step, such as by laser cutting or die stamping.

[0179] In an exemplary embodiment, after forming a boss 5109 at a position corresponding to the spacer groove 5113 on the first side portion 5108 of the first board 5106 (i.e., step a112), the above-described steps for fabricating the flexible circuit board (i.e., step a110) further include:

[0180] a113) The electrode holder 5200 (see also the fitting) is provided with a groove 201 corresponding to the boss 5109. Figure 43 Installed to the first side 5108 of the first plate 5106 (see fitting details). Figure 34 and Figure 37 The boss 5109 is then inserted into the groove 201 of the electrode holder 5200, causing the sidewall 205 of the groove 201 to press against the boss 5109 (see details). Figure 47 This allows the portion of the insertion space 5112 located on the boss 5109 to remain open.

[0181] After the insertion space 5112 is formed and the separation tool is removed, the upper and lower flexible plates of the insertion space 5112 (i.e., Figure 35 The flexible plates 5102 and 5103 in the middle will gradually return to a near parallel state so that the contacts in the insertion space 5112 can maintain contact with the electrode body 9000 inserted into the insertion space 5112 to ensure electrical connection.

[0182] However, the upper and lower flexible plates of the insertion space 5112 (i.e. Figure 35 After the flexible plates 5102 and 5103 in the middle return to a nearly parallel state, it is not conducive to the insertion of the electrode body 9000. Therefore, the side wall of the groove 201 squeezes the boss 5109 so that the part of the insertion space 5112 located on the boss 5109 can remain open to facilitate the insertion of the electrode body 9000.

[0183] In an exemplary embodiment, the above-described steps for fabricating the flexible circuit board (i.e., step a110) further include:

[0184] (a114) An antenna plate 5114 extending in the second direction is fabricated on the flexible circuit board 1000. The antenna plate 5114 is integrally formed with the second plate 5107 (see details for details). Figure 34 ).

[0185] The order of steps a111, a112, and a114 can be adjusted.

[0186] In traditional manufacturing processes, the right end of the antenna plate 5114 does not exceed the length of the first plate 5106 in the y-axis direction. Since the antenna itself has certain length requirements, this results in an excessively long overall length of the conductive connection structure. Therefore, a solution can be chosen where the antenna plate 5114 extends to one side of the first plate 5106, with the antenna plate 5114 located on the positive x-axis side of the first plate 5106 (see reference for details). Figure 39 Alternatively, antenna plate 5114 can also be located on the negative x-axis side of first plate 5106 (not shown) (i.e., antenna plate 5114 is located on...). Figure 39 (At the top edge of the first plate 5106 in the middle).

[0187] In one embodiment, the length of antenna plate 5114 is less than the length of first plate 5106 (see also [reference]). Figure 39 ).

[0188] Specifically, laser cutting and other processes can be used to cut the flexible circuit board 1000 along the second direction (i.e. Figure 39 Cut a spacer groove 5115 along the y-axis direction, and along the first direction (i.e., Figure 39A spacer groove 5116 is cut along the x-axis direction of the first plate 5106. The length of the spacer groove 5115 is less than the length of the first plate 5106. One end of the spacer groove 5115 is connected to the spacer groove 5116, and the spacer groove 5115 and the spacer groove 5116 form an L-shaped groove (see [reference] for details). Figure 39 The area enclosed by the spacers 5115 and 5116 can serve as the antenna plate 5114.

[0189] The other end of the spacer 5115 can be connected to one end of a spacer 5113, so that spacer 5113, spacer 5115, and spacer 5116 form a Z-shaped groove (see details). Figure 39 ).

[0190] During the process of the slot 5111 expanding into the insertion space 5112, the spacer slots 5115 and 5116 can ensure that the antenna board 5114 is not affected by the expansion process.

[0191] As the gap 5111 expands into the insertion space 5112, the portion of the first plate 5106 near the antenna plate 5114 will arch (flexible plates 5101 and 5102 arch upwards, while flexible plates 5103 and 5104 arch downwards), causing this portion to gradually move away from the antenna plate 5114, that is, the spacer slot 5115 gradually expands (see also...). Figure 34 and Figure 36 ).

[0192] In another embodiment, the length of antenna plate 5114 is equal to the length of first plate 5106 (see also [reference]). Figure 42 ).

[0193] Specifically, laser cutting and other processes can be used to cut the flexible circuit board 1000 along the second direction (i.e. Figure 42 A spacer slot 5115 is cut out along the y-axis direction. The length of the spacer slot 5115 is equal to the length of the first plate 5106. The area below the spacer slot 5115 can be used as the antenna plate 5114.

[0194] The above-described implementation schemes all involve fabricating the antenna board 5114 through laser cutting, die stamping, or other methods. Alternatively, the flexible circuit board 1000 can be omitted, and a portion of the first board 5106 can be directly used as the antenna board. For example, in... Figure 40 In the middle, only one spacer slot 5113 is provided, and the part of the first plate 5106 that is away from the spacer slot 5113 in the positive x-axis direction can be used as the antenna plate 5114.

[0195] The antenna of the entire flexible circuit board 1000 is along the second direction (i.e. Figure 39 It extends along the y-axis and is arranged on the second plate 5107 and the antenna plate 5114.

[0196] In an exemplary embodiment, after the separation tool is removed after forming the insertion space 5112, and each insertion space constitutes a connection terminal group 1100 (i.e., step a130), the step of fabricating the flexible circuit board (i.e., step a) further includes:

[0197] (a140) The protective layer 5300 is wrapped around the outside of the flexible circuit board 1000 and the electrode holder 5200 (see details for details). Figure 45 and Figure 46 ).

[0198] When the protective layer 5300 is wrapped, the flexible plates 5102 and 5103 are not fully opened, but are partially opened and wrapped with silicone. When the electrode body 9000 is inserted into the insertion space 5112, the protective layer 5300 will also provide pressure to keep the insertion space 5112 in contact with the electrode body 9000 to ensure electrical connection.

[0199] For example, when the gap 5111 is opened into the insertion space 5112, a first steel rod with a diameter of D is used to open it. However, when wrapping the protective layer 5300, a second steel rod with a diameter of 0.9D needs to be inserted. At this time, the insertion space 5112 is not fully opened, but in a semi-open state. The purpose is that after wrapping the protective layer 5300, the insertion space 5112 is in a semi-compressed state. When the electrode body 9000 is inserted, it is fully opened again, so that the protective layer 5300 has a relative pressure on the electrode body 9000, so that the insertion space 5112 and the electrode body 9000 keep in contact to ensure electrical connection.

[0200] The diameter of the second steel bar is smaller than the diameter of the first steel bar.

[0201] The protective layer 5300 can be made of materials such as silicone, TPU, PGL, and PEEK, and formed through molding, injection molding, etc.

[0202] The number of electrode holders 5200 corresponds to the number of bosses 5109. Each electrode holder 5200 is provided with a groove 5201 corresponding to a boss 5109 and a cavity 5202 corresponding to an insertion space (see mating details). Figure 43 , Figure 44 and Figure 47 The electrode holder 5200 is mounted on the first side 5108 of the first plate 5106 (see mating details). Figure 36 and Figure 37 And the boss 5109 is locked in the groove 5201 of the electrode holder 5200.

[0203] In an exemplary embodiment, the electrode holder 5200 is provided with a through fastening hole 5203. The fastening hole 5203 is perpendicular to the cavity 5202 and communicates with the cavity 5202. By cooperating with the fastener (not shown) and the fastening hole 5203, the electrode body 9000 can be fixed in the insertion space 5112 and the cavity 5202.

[0204] In an exemplary embodiment, the electrode holder 5200 is provided with a protrusion 5204 (see also [reference]). Figure 43 The first side portion 5108 of the first board 5106 is provided with a solder pad 5117 (see also the following for details). Figure 36 The protrusion 5204 of the electrode holder 5200 is welded to the pad 5117 of the first plate 5106.

[0205] In an exemplary embodiment, after the step of inserting the proximal end of the electrode body 9000 into the corresponding connection terminal group 1100 of the flexible circuit board 1000 (i.e., step c), the method of manufacturing the implantation device further includes:

[0206] The electrode body 9000 is fixed on the flexible circuit board 1000 using the electrode holder 5200.

[0207] An opening 5301 is provided in the protective layer 5300 at a position corresponding to the electrode holder, which facilitates the operation of the electrode holder 5200.

[0208] The present invention also provides an implantation device, comprising: a flexible circuit board 1000 and at least one electrode body 9000.

[0209] The flexible circuit board 1000 is provided with at least one connection terminal group 1100.

[0210] At least one electrode body 9000 has a tail end electrode ring group 9001 at its proximal end and a head end electrode ring group 9002 at its distal end.

[0211] The proximal end of the electrode body 9000 can be inserted into the corresponding connection terminal group 1100 of the flexible circuit board 1000, so that the tail electrode ring group of the proximal end is electrically connected to the corresponding connection terminal group 1100.

[0212] This invention separates the electrode body 9000 and the flexible circuit board 1000. The user can directly insert the electrode body 9000 into the connection terminal group 1100 of the circuit board by hand to achieve electrical connection. This method of connection is reliable, low cost, simple to manufacture, and can be installed and disassembled relatively easily.

[0213] In an exemplary embodiment, the implantation device further includes: an electrode holder 5200, the electrode holder being mounted to the flexible circuit board 1000 (see also [reference]). Figure 1 ), and is used to fix the electrode body 9000 to the flexible circuit board.

[0214] In an exemplary embodiment, each electrode body 9000 includes: a first tube body 9100, a second tube body 9200, a packing tube 9300, 2n wires, and a single-cavity tube 9500.

[0215] The first tube 9100 and the second tube 9200 are connected by 2n wires. The 2n wires pass through 2n peripheral cavities of the first tube 9100 and the second tube 9200 respectively and surround the central cavity of the first tube 9100 and the second tube 9200.

[0216] The packing tube 9300 is located between the first tube body 9100 and the second tube body 9200, and the axial position of the packing tube 9300 is aligned with the axial position of the first tube body 9100 and the axial position of the second tube body 9200.

[0217] 2n wires are wrapped around the 9300-degree filler tube.

[0218] The single-lumen tube 9500 encloses the end of the first tube body 9100 near the packing tube 9300, the 2n wires between the first tube body 9100 and the second tube body 9200, the packing tube 9300, and the end of the second tube body 9200 near the packing tube 9300.

[0219] The first tube body 9100, the packing tube 9300, the second tube body 9200, and the single-lumen tube 9500 are integrated into one unit.

[0220] In an exemplary embodiment, the first tube 9100 and the second tube 9200 each contain 2n+1 cavities extending along the axial direction of the tube, one of which is a central cavity located at the axis of the tube, and the remaining 2n peripheral cavities are distributed around the central cavity, where n is an integer greater than or equal to 1 and less than or equal to 8, and 2n wires are respectively inserted into the 2n peripheral cavities of the first tube and the second tube.

[0221] In an exemplary embodiment, the first tube 9100 and the second tube 9200 each include: 2n slits, 2n wires, and 2n electrode rings.

[0222] 2n incisions are formed on the outer wall of the tube in a predetermined order and at predetermined intervals along the axial and circumferential directions of the tube, with each incision exposing an outer peripheral lumen.

[0223] 2n wires are respectively inserted into 2n peripheral lumens of the first tube 9100 and the second tube 9200, and each has an exposed end that passes through a cut on the peripheral lumen.

[0224] 2n electrode rings are sequentially and alternately placed on the outer wall of the tube and cover 2n slits respectively, thereby electrically connecting to the exposed ends of 2n wires respectively.

[0225] Among them, the 2n electrode rings located on the first tube 9100 are head electrode rings and form the head electrode ring group at the distal end, and the 2n electrode rings located on the second tube 9200 are tail electrode rings and form the tail electrode ring group at the proximal end.

[0226] For example Figure 3 As shown, the first tube 9100 and the second tube 9200 are connected by eight wires (such as the first wire 9111, the second wire 9112, the third wire 9113, etc.). These eight wires pass through the eight outer cavities of the first tube 9100 and the second tube 9200 respectively and surround the central cavity 9120 of the first tube 9100 and the second tube 9200. Figure 4 As shown, the packing tube 9300 is located between the first tube body 9100 and the second tube body 9200, and the axis of the packing tube 9300 is aligned with the axis of the first tube body 9100 and the axis of the second tube body 9200. Eight wires are wound around the packing tube 9300. Figure 13 As shown, the single-lumen tube 500 encloses the end of the first tube body 9100 near the packing tube 9300, the eight wires between the first tube body 9100 and the second tube body 9200, the packing tube 9300, and the end of the second tube body 9200 near the packing tube 9300. The first tube body 9100, the packing tube 9300, the second tube body 9200, and the single-lumen tube 9500 are integrated into one unit.

[0227] like Figure 3 As shown, the first tube 9100 and the second tube 9200 each contain nine cavities extending along the axial direction of the tube. One central cavity (e.g., central cavity 9120) is located at the axis of the first tube 9100, and the other eight peripheral cavities are distributed around the central cavity 9120. Eight wires are inserted into the eight peripheral cavities of the first tube 9100 and the second tube 9200, respectively.

[0228] like Figure 7As shown, the first tube 9100 and the second tube 9200 each include eight incisions. These eight incisions are formed on the outer walls of the first tube 9100 and the second tube 9200 along the axial and circumferential directions of the tubes in a predetermined order and at predetermined intervals. Each incision exposes an outer peripheral lumen; for example, the first incision 9131 exposes a first outer peripheral lumen 9121. Eight wires are respectively inserted into the eight outer peripheral lumens of the first tube 9100 and the second tube 9200 and each has an exposed end passing through an incision in the outer peripheral lumen. For example, the first wire 9111 has a protruding end 9141 passing through the first incision 9131, and the second wire 9112 has a protruding end 9142 passing through the second incision 9132. Figure 14 As shown, the first tube 9100 and the second tube 9200 each have 8 electrode rings that are sequentially and alternately fitted onto the outer wall of the tube and cover 8 cuts, thereby being electrically connected to the exposed ends of 8 wires respectively.

[0229] The advantages of the above-mentioned electrode are as follows:

[0230] 1) By simultaneously arranging 2n wires in the 2n outer circumference cavities of the pipe body, the wires are fully isolated from each other and there is no risk of contact, thus avoiding the occurrence of short circuits;

[0231] 2) It does not require the conventional perfusion method used in existing technologies. The method is simpler to operate and the product is more flexible. When implanted into the human body, it can adapt well to the corresponding parts of the human body.

[0232] 3) The tube body of the multi-conducting elastic electrode is integrally molded, which improves the product strength. After heat shrinking treatment, the outer periphery of the tube body tightly wraps the wire, preventing the wire from moving undesirably in the outer periphery and detaching from the electrode ring.

[0233] 4) After heat shrinking treatment, the gap between the electrode ring and the outer wall of the tube is filled by the molten tube material, which prevents the electrode ring from moving undesirably on the outer wall of the tube and from becoming disconnected from the wire.

[0234] 5) After heat shrinking, the gaps between the tube body, the filler tube, and the single-lumen tube are filled with material, which effectively reduces the risk of the entire electrode failing due to leakage of body fluids (blood, tissue fluid, etc.) and contact with internal wires after the electrode is implanted in the human body.

[0235] 6) Because a polygonal cross-section filler tube is used, the wire portion located between the first tube and the second tube can be evenly distributed around the outer periphery of the filler tube, which can avoid mutual cross-entanglement and interference between wires and accidental short circuits during the manufacturing process and after the finished product.

[0236] 7) Since the materials used as conductors, such as MP35N, have poor weldability, it is even more difficult to ensure the strength of the weld if the weld point is small. By introducing a riveted metal ring between the conductor and the electrode ring, the contact area of ​​the welded part can be significantly increased, thereby enhancing the weld strength.

[0237] Example 1

[0238] Two 9-hole tubes are provided, with one central lumen located at the axis of the 9-hole tube, and the remaining eight peripheral lumens evenly distributed around the central lumen. The tubes are made of thermoplastic polyurethane. The outer diameter of the tube is 1.3 mm, the inner diameter of each peripheral lumen is 0.21 mm, and the inner diameter of the central lumen is 0.51 mm.

[0239] Eight incisions are made on the outer walls of the two tubes along the axial and circumferential directions in a predetermined incision sequence and at predetermined incision intervals, with each incision exposing at least one peripheral lumen.

[0240] First, each tube is placed on a specially designed cutting fixture, allowing it to move freely along both the axial and circumferential directions. After determining the proximal and distal ends of the tubes, a first cut is arbitrarily selected on the outer wall of the distal end of each tube. Then, on the tooling, each tube body can be rotated 45° clockwise in the circumferential direction and moved 7 mm towards the proximal end in the axial direction to select the second cut position. Then, the tube body can be rotated 90° counterclockwise in the circumferential direction and moved 7 mm towards the proximal end in the axial direction to select the third cut position. Then, the tube body can be rotated 135° clockwise in the circumferential direction and moved 7 mm towards the proximal end in the axial direction to select the fourth cut position. Then, the tube body can be rotated 180° counterclockwise in the circumferential direction and moved 7 mm towards the proximal end in the axial direction to select the fifth cut position. Then, the tube body can be rotated 225° clockwise in the circumferential direction and moved 7 mm towards the proximal end in the axial direction to select the sixth cut position. Then, the tube body can be rotated 270° counterclockwise in the circumferential direction and moved 7 mm towards the proximal end in the axial direction to select the seventh cut position. Then, the tube body can be rotated 315° clockwise in the circumferential direction and moved 7 mm towards the proximal end in the axial direction to select the eighth cut position. In this step, each cut is 0.3 mm deep and is parallel to the circumferential direction of the tube.

[0241] One wire is inserted into each corresponding outer circumferential cavity of the two tubes, ensuring that the wires are substantially parallel to the axial direction of the tubes and do not cross each other. The wires are made of MP35N material. Each wire has a diameter of 0.15 mm.

[0242] Starting from the first incision 9131 closest to the distal end on the first tube 9100, one end of the first conductor 9111 in the first peripheral cavity 9121 is protruded. A metal ring 9151 is riveted to the protruding end of the first conductor 9111 in the first peripheral cavity 9121, wherein the riveted metal ring 9121 is arc-shaped and its curved surface is consistent with the inner surface of the electrode ring. The metal ring 9151 is made of platinum-iridium alloy. The outer diameter of the metal ring 9151 is 0.33 mm, the inner diameter is 0.21 mm, and the length is 1.5 mm. Subsequently, the first end electrode ring is fitted onto the first tube 9100 from the proximal end of the first tube 9100, covering the first incision 9131. The riveted metal ring 9151 is resistance welded to the inner surface of the first end electrode ring, thereby completing the electrical connection between the first conductor 9111 and the first end electrode ring. Repeat the above steps from the distal end to the proximal end to pick up the wire, weld the electrode ring and the wire, until the 8th head electrode ring covers the 8th cut on the first tube from the distal end to the proximal end and is electrically connected to the picked-out end of the 8th wire.

[0243] Starting from the first incision closest to the distal end on the second tube 9200, the other end of the first conductor in the first outer peripheral cavity is protruded. A metal ring is riveted to the protruding end of the first conductor 9111 in the first outer peripheral cavity of the second tube 9200, wherein the riveted metal ring is arc-shaped and its curved surface is consistent with the inner surface of the electrode ring. The metal ring is made of platinum-iridium alloy. The outer diameter of the metal ring is 0.33 mm, the inner diameter is 0.21 mm, and the length is 1 mm. Subsequently, the first tail electrode ring is fitted onto the second tube 9200 from the proximal end of the second tube 9100, covering the first incision. The riveted metal ring is resistance welded to the inner surface of the first tail electrode ring, thereby completing the electrical connection between the first conductor and the first tail electrode ring. Repeat the above steps from the distal end to the proximal end to pick up the wire, weld the electrode ring and the wire, until the 8th tail electrode ring covers the 8th cut on the second tube from the distal end to the proximal end and is electrically connected to the picked-out end of the 8th wire.

[0244] Subsequently, a filler tube 9300 is inserted between the first tube 9100 and the second tube 9200, such that the portions of the 2n wires between the first tube 9100 and the second tube 9200 surround the filler tube 9300, with the axis of the filler tube 9300 aligned with the axes of the first tube 9100 and the second tube 9200. A mandrel 9400 is then inserted into the central cavity 9120 of the first tube 9100, the central cavity of the filler tube 9300, and the central cavity of the second tube 9200, so that the first tube 9100, the filler tube 9300, and the second tube 9200 come into contact sequentially. In this step, the mandrel 9400 extends through the entire length of the multi-conductive elastic electrode. The diameter of the mandrel 9400 is 0.50 mm. The mandrel 9400 is made of stainless steel and its surface is coated with polytetrafluoroethylene.

[0245] Each electrode ring is made to completely cover its corresponding cut, and the eight electrode rings on each tube are pre-compressed to reduce their diameter. The eight electrode rings on each tube are then forged so that the outer diameter of the electrode ring matches the outer diameter of the tube, and each electrode ring is fixed to the outer wall of the tube by forging.

[0246] A single-lumen tube 9500 is used to enclose the end of the first tube 9100 near the packing tube 9300, the 2n wires between the first tube 9100 and the second tube 9200, the packing tube 9300, and the end of the second tube 9100 near the packing tube 9300. The single-lumen tube 9500 has an outer diameter of 2.3 mm and an inner diameter of 1.7 mm.

[0247] Heat shrink tubing is fitted onto the eight electrode rings on each of the two tube bodies, the outer wall of the tube body not covered by the electrode rings, and the outer wall of the single-lumen tube, and heated to a temperature greater than or equal to the heat shrinking temperature of the heat shrink tubing. At this temperature, the heat shrink tubing shrinks, and the materials of the two tube bodies, the filler tube, and the single-lumen tube melt, so that all the outer cavities of the first tube body 9100 and the second tube body 9200 tightly wrap their respective wires. The molten single-lumen tube and the filler tube fill the gaps between the eight wires to tightly wrap all the wires. The gaps between the eight head electrode rings and the outer wall of the first tube body 9100, and between the eight tail electrode rings and the outer wall of the second tube body 9200, are also filled by the molten tubing material, so that the electrode rings are tightly fitted to the outer wall of the tube body. The first tube body 9100, the second tube body 9200, and the single-lumen tube 9500 between them are also fused together due to the compression and filling of the above structure. Afterwards, the heat shrink tubing and the two tube bodies, the single-lumen tube, and the electrode rings it wraps are cooled. The heat shrink tubing is made of perfluoroethylene-propylene copolymer. The heat shrink tubing has an outer diameter of 2.7 mm and an inner diameter of 2.5 mm. The heat shrink tubing is then peeled off, and the mandrel is removed. Finally, the distal end of the first tubing is heat-softened and cooled to seal the end.

[0248] During the tip molding and sealing process, a titanium alloy plug can be pre-installed to prevent the guide wire from puncturing the sealed end made of plastic.

[0249] In an exemplary implementation, such as Figures 9 to 11 As shown, the wire is electrically connected to the corresponding electrode ring through a riveting component.

[0250] Among them, the riveting part is a metal ring 9151 riveted into an arc shape. The curved surface of the metal ring 9151 is consistent with the inner surface of the electrode ring (e.g., the first electrode ring 9161) and is welded to the inner surface of the electrode ring (e.g., the first electrode ring 9161).

[0251] In an exemplary embodiment, a positioning anchor 9600 is provided on the first tube 9100 of the electrode body 9000. The function of the positioning anchor 9600 is to suture and fix the positioning anchor 9600 to the intervertebral ligament tissue with sutures, and the first tube 9100 can be fixed by the positioning anchor 9600.

[0252] A tension-reducing ring can be placed between the external spinal cord, the flexible circuit board 1000, and the positioning anchor 9600. The tension-reducing ring is used to buffer external stretching and prevent the first tube 9100 implanted in the spinal cord from being pulled.

[0253] In an exemplary implementation, such as Figures 15 to 19 As shown, each of at least one connection terminal group includes a plurality of resilient connection terminals 2100, and each resilient connection terminal 2100 includes: a bracket 2110 and two resilient arc plates 2120.

[0254] The bottom of bracket 2110 is fixed to flexible circuit board 1000.

[0255] Two flexible arc-shaped plates 2120 are disposed at the top of the bracket 2110. Each of the two flexible arc-shaped plates 2120 is recessed in a direction away from each other to form a clamping space 2121 (see also the fitting details). Figure 15 and Figure 16 Furthermore, the two elastic arc plates 2120 can provide clamping force to the electrode body 9000 inserted into the clamping space 2121.

[0256] When the electrode body 9000 is inserted into the clamping space 2121, the electrode body 9000 will expand the two elastic arc plates 2120 so that the two elastic arc plates 2120 provide clamping force to the electrode body 9000, so that the electrode body is supported in the clamping space 2121.

[0257] The present invention separates the electrode body 9000 and the flexible circuit board 1000. The electrode body 9000 can be manually inserted into the elastic connection terminal 2100 of the circuit board. This method of connection is reliable, low cost, simple to manufacture, and can be installed and disassembled relatively easily.

[0258] When not in use (i.e., when electrode 9000 is not inserted), the top ends of the two elastic arc plates 2120 (i.e., the ends furthest from the bracket 2110) can be in a non-contact state (i.e., there is a gap) (see mating details). Figure 15 and Figure 16 It can also be in a contact state (i.e., there is no gap) (not shown).

[0259] In an exemplary embodiment, the bottom of the bracket 2110 is flat to allow it to be soldered to the circuit board.

[0260] In an exemplary implementation, such as Figures 15 to 17As shown, the bracket 2110 includes a first inclined plate 2111, a base plate 2112, and a second inclined plate 2113 connected in sequence. Each of the first inclined plate 2111 and the second inclined plate 2113 has an elastic arc-shaped plate 2120 connected to its top end.

[0261] In an exemplary embodiment, the first inclined plate 2111, the base plate 2112, and the second inclined plate 2113 form a triangular structure (see also [reference]). Figure 16 It has stability.

[0262] In an exemplary embodiment, the base plate 2112 is soldered to the circuit board.

[0263] In an exemplary embodiment, the material of the flexible connection terminal 2100 is beryllium bronze, and the flexible connection terminal 2100 is formed by stamping using a stamping die.

[0264] Beryllium bronze has high hardness, elastic limit, fatigue limit and wear resistance, as well as good corrosion resistance, thermal conductivity and electrical conductivity.

[0265] The type of material used for the flexible connection terminal 2100 is not limited to this; it can be any material in the prior art, as long as it can achieve the above-mentioned functions.

[0266] In an exemplary implementation, such as Figures 15 to 17 As shown, each of the two elastic arc plates 2120 has a flange structure 2122 on its front and rear sides to guide the insertion of the electrode body 9000, ensuring that the insertion of the electrode body 9000 is still unobstructed even when the coaxiality of multiple sets of spring sheets is inaccurate.

[0267] In an exemplary implementation, such as Figures 15 to 17 As shown, an opening 2114 is provided between the first inclined plate 2111 and the corresponding elastic arc plate 2120, and between the elastic arc plate 2120 corresponding to the second inclined plate 2113, to reduce the clamping force.

[0268] Multiple flexible connection terminals 2100 are arranged in a row to form a connection terminal group 1100, and an electrode body 9000 is simultaneously inserted into multiple flexible connection terminals 2100.

[0269] In an exemplary implementation, such as Figure 18 and Figure 19 As shown, the proximal end of the electrode body 9000 has multiple electrode rings 9003.

[0270] One electrode ring 9003 is located within the corresponding electrode holder 5200 and is electrically connected to the inner surface of the electrode holder 5200. The remaining electrode rings 9003 are located within the corresponding clamping spaces 2121 and are electrically connected to the inner surface of the corresponding clamping spaces 2121.

[0271] The above implementation scheme takes multiple flexible connection terminals 2100 arranged in a row as an example. In addition, multiple flexible connection terminals 2100 can be arranged in multiple rows (i.e., forming multiple connection terminal groups 1100) to insert multiple electrode bodies 9000.

[0272] The electrode body 9000 can be directly inserted into multiple elastic connection terminals 2100 arranged in a row. Each electrode ring 2902 will expand two elastic arc plates 2120 in the clamping space 2121 of the corresponding elastic connection terminal 2100 so that the two elastic arc plates 2120 provide clamping force. The clamping force will make the electrode body 9000 supported in the clamping space 2121 under the action of the two elastic arc plates 2120.

[0273] In an exemplary implementation, such as Figures 20 to 24 As shown, each of at least one connection terminal group includes a plurality of first quick connectors 3100, each first quick connector 3100 including: a first connector body 3110, a top bead 3120 and a first elastic member 3130.

[0274] The first connecting seat body 3110 is provided with a first direction (i.e. Figure 22 The first receiving cavity 3111 extends along the x-axis direction and along the second direction (i.e., Figure 22 The first insertion cavity 3112 of the first connector body 3110 (in the y-axis direction) passes through the first insertion cavity 3112 of the first connector body 3110, and the first receiving cavity 3111 is connected to the first insertion cavity 3112. The first connector body 3110 is disposed on the flexible circuit board 1000.

[0275] The top bead 3120 is disposed at a position in the first receiving cavity 3111 that communicates with the first insertion cavity 3112, and a portion of the top bead 3120 can extend into the first insertion cavity 3112.

[0276] The first elastic member 3130 is disposed in the first receiving cavity 3111 and provides elastic support for the top bead 3120.

[0277] When the electrode body 9000 passes through the first insertion cavity 3112 along the second direction, the electrode body 9000 presses the first elastic member 3130 through the top bead 3120, so that the electrode body 9000 is supported in the first insertion cavity 3112 under the action of the first elastic member 3130.

[0278] The operator directly inserts the electrode body 9000 into the first insertion cavity 3112 and uses the first elastic member 3130 to support the electrode body 9000 in the first insertion cavity 3112. The operation is simple and no additional tools are needed. Moreover, the processing and manufacturing are easy and the process is simple, which can get rid of the constraints of imported raw materials.

[0279] In an exemplary implementation, such as Figure 21 and Figure 22 As shown, the end of the first connector body 3110 away from the first insertion cavity 3112 is provided with a mounting groove 3113 and an end cap 3114. The mounting groove 3113 is connected to the first receiving cavity 3111, and the end cap 3114 is installed in the mounting groove 3113. The end cap 3114 can be removed from the mounting groove 3113 to install the first elastic member 3130 and the top bead 3120.

[0280] Specifically, the top bead 3120 and the first elastic member 3130 are sequentially inserted from the mounting groove 3113 into the first receiving cavity 3111, and then the end cap 3114 is installed in the mounting groove 3113 to restrict the top bead 3120 and the first elastic member 3130 within the first receiving cavity 3111.

[0281] In an exemplary embodiment, the end cap 3114 is riveted into the mounting groove 3113.

[0282] In an exemplary implementation, such as Figure 21 and Figure 22 As shown, a limiting wall 3115 is provided at the position where the first receiving cavity 3111 communicates with the first insertion cavity 3112. An opening 3116 is provided on the limiting wall 3115. The first receiving cavity 3111 is connected to the first insertion cavity 3112 through the opening 3116. The diameter of the opening 3116 is smaller than the diameter of the top bead 3120 to prevent the top bead 3120 from falling out of the first receiving cavity 3111.

[0283] In one embodiment, the first elastic member 3130 and the top bead 3120 are independent parts.

[0284] In another embodiment, the first elastic member 3130 and the top bead 3120 are formed as one unit.

[0285] In an exemplary embodiment, the first elastic member 3130 is selected as a spring. The type of the first elastic member 3130 is not limited to this, and it can be any form in the prior art, as long as it can achieve the above-mentioned function.

[0286] In an exemplary implementation, such as Figure 20 and Figure 21 As shown, the first insertion cavity 3112 is provided with two symmetrical conical grooves 3117.

[0287] In this design, the outer diameter of each conical groove 3117 is larger than the inner diameter, and the conical groove 3117 can guide the insertion of the electrode body 9000.

[0288] In an exemplary embodiment, the first direction is perpendicular to the second direction.

[0289] In this configuration, multiple first quick connectors 3100 are arranged in a row to form a connection terminal group 1100, and the electrode body 9000 is simultaneously inserted into multiple first quick connectors 3100.

[0290] In an exemplary implementation, such as Figure 23 and Figure 24 As shown, the proximal end of the electrode body 9000 has multiple electrode rings 9003.

[0291] One electrode ring 9003 is located in the corresponding electrode holder and is electrically connected to the inner surface of the electrode holder. The other electrode rings 9003 are located in the corresponding first insertion cavity 3112 and are electrically connected to the inner surface of the corresponding first insertion cavity 3112.

[0292] Specifically, the electrode ring 902 is electrically connected to the portion of the inner surface of the first insertion cavity 3112 that is opposite to the top bead 3120.

[0293] The above implementation scheme takes the arrangement of multiple first quick connectors 3100 in a row as an example. In addition, multiple first quick connectors 3100 can be arranged in multiple rows (i.e., forming multiple connection terminal groups 1100) to insert multiple electrode bodies 9000.

[0294] The electrode body 9000 can be directly inserted into multiple first quick connectors 3100 arranged in a row. Each electrode ring 902 will squeeze the top bead 3120 in the corresponding first insertion cavity 3112 to further squeeze the first elastic member 3130, so that the electrode body 9000 is supported in the first insertion cavity 3112 under the action of the first elastic member 3130.

[0295] In an exemplary embodiment, each of at least one connection terminal group includes a plurality of second quick connectors 4100, each second quick connector 4100 including: a second connector body 4110 and a second elastic member 4130.

[0296] The second connector body 4110 is provided with a second insertion cavity 4113 penetrating through the first surface 4111 and the second surface 4112 of the second connector body 4110, and a second receiving cavity 4114 communicating with the second insertion cavity 4113 (see also the corresponding reference). Figures 25 to 30 ), and support holes located on the two opposite sidewalls 4115 and 4116 of the second receiving cavity 4114.

[0297] The second elastic member 4130 includes an integrally formed arc-shaped plate 4131 and plug-in plates 4132 and 133 disposed on both sides of the arc-shaped plate 4131 (see details for matching). Figure 26 and Figure 31 The arc-shaped plate 4131 is disposed within the second receiving cavity 4114 and a portion of the arc-shaped plate 4131 can extend into the second insertion cavity 4113 (see mating details). Figure 26 Each plug-in plate 4132, 4133 is set in the corresponding support hole.

[0298] The second elastic member 4130 can provide elastic support for the electrode body 9000 inserted into the second insertion cavity 4113.

[0299] The operator can directly insert the electrode body 9000 into the second insertion cavity 4113 and use the second elastic member 4130 to support the electrode body 9000 in the second insertion cavity 4113. The operation is simple and no additional tools are needed. Moreover, the processing and manufacturing are easy and the process is simple.

[0300] In an exemplary embodiment, the second connector body 4110 is generally rectangular in shape.

[0301] In one implementation scheme, such as Figures 27 to 30 As shown, the support holes include a first support hole 4117 located on the first surface 4111 of the second connector body 4110 and a second support hole 4118 located on the second surface 4112 of the second connector body 4110 (i.e., the side wall 4115 is part of the first surface 4111, and the side wall 4116 is part of the second surface 4112).

[0302] The plug-in plate 4132 is disposed in the first support hole 4117, and the plug-in plate 4133 is disposed in the second support hole 4118.

[0303] In another embodiment, the first support hole 4117 and the second support hole 4118 may also be located on two other opposing surfaces of the second connecting body 4110, namely the third surface 4119 and the fourth surface 4120.

[0304] In an exemplary implementation, such as Figure 30 As shown, the second insertion cavity 4113 is along the second direction (i.e. Figure 30 The second receiving cavity 4114 extends along the first direction (i.e., the y-axis direction) to penetrate the first surface 4111 and the second surface 4112 of the second connecting seat body 4110, and the second receiving cavity 4114 extends along the first direction (i.e., the y-axis direction) to penetrate the first surface 4111 and the second surface 4112 of the second connecting seat body 4110. Figure 30 (in the x-axis direction) extends to connect the exterior of the second connector body 4110 and the second insertion cavity 4113.

[0305] In an exemplary implementation, such as Figure 29 and Figure 30 As shown, a first guide groove 4121 is provided on the side of the second receiving cavity 4114 away from the second insertion cavity 4113.

[0306] The first guide groove 4121 can guide the insertion of the second elastic member 4130.

[0307] In one embodiment, the first guide groove 4121 is a conical groove (see reference for details). Figure 29 and Figure 30 ).

[0308] In another embodiment, the first guide groove 4121 is an arc-shaped groove (not shown).

[0309] In one embodiment, the first support hole 4117 and the second support hole 4118 are through holes (see details). Figure 29 ).

[0310] In another embodiment, the first support hole 4117 and the second support hole 4118 are blind holes (not shown).

[0311] In yet another embodiment, one of the first support hole 4117 and the second support hole 4118 is a through hole, and the other of the first support hole 4117 and the second support hole 4118 is a blind hole (not shown).

[0312] In an exemplary embodiment, the thickness L1 of the plug-in plate 4132 is less than the height H1 of the first support hole 4117, and the thickness L2 of the plug-in plate 4133 is less than the height H2 of the second support hole 4118 (see also [reference]). Figure 29 and Figure 31 This design allows the plug plate 4132 to have a certain amount of deformation space within the first support hole 4117, facilitating its insertion into the first support hole 4117. Similarly, the plug plate 4133 allows a certain amount of deformation space within the second support hole 4118, facilitating its insertion into the second support hole 4118. This allows the second elastic member 4130 to undergo elastic deformation without breaking when compressed by the electrode body 9000 inserted into the second plug cavity 4113, thus achieving contact circuit conduction. When the electrode body 9000 is pulled out, the second elastic member 4130 returns to its initial state. This process can be repeated, allowing for multiple insertions and removals without damaging the product.

[0313] In an exemplary implementation, such as Figure 29 and Figure 30 As shown, the two ends of the second insertion cavity 4113 are provided with second guide grooves 4122.

[0314] The second guide groove 4122 can guide the insertion of the electrode body 9000.

[0315] In one embodiment, the second guide groove 4122 is an arc-shaped groove (see reference for details). Figure 29 and Figure 30 ).

[0316] In another embodiment, the second guide groove 4122 is a tapered groove (not shown).

[0317] During assembly, the arc-shaped plate 4131 of the second elastic member 4130 can be aligned with the second receiving cavity 4114 for insertion into the second receiving cavity 4114. The sidewall of the second receiving cavity 4114 will compress the second elastic member 4130, causing the second elastic member 4130 to undergo elastic deformation.

[0318] After the insertion plate 4132 of the second elastic member 4130 is aligned with the first support hole 4117 and the insertion plate 4133 is aligned with the second support hole 4118, the second elastic member 4130 is squeezed from the second insertion cavity 4113 using the corresponding tools, so that the insertion plate 4132 is inserted into the first support hole 4117 and the insertion plate 4133 is inserted into the second support hole 4118.

[0319] Multiple second quick connectors 4100 are arranged in a row to form a connection terminal group 1100, and an electrode body 9000 is simultaneously inserted into multiple second quick connectors 4100.

[0320] In an exemplary implementation, such as Figure 32 and Figure 33 As shown, the proximal end of the electrode body 9000 has multiple electrode rings 9003.

[0321] One electrode ring 9003 is located in the corresponding electrode holder and is electrically connected to the inner surface of the electrode holder. The other electrode rings 9003 are located in the corresponding second insertion cavity 4113 and are electrically connected to the inner surface of the corresponding second insertion cavity 4113.

[0322] The above implementation scheme takes the arrangement of multiple second quick connectors 4100 in a row as an example. In addition, multiple second quick connectors 4100 can be arranged in multiple rows (i.e., forming multiple connection terminal groups 1100) to insert multiple electrode bodies 9000.

[0323] The electrode body 9000 can be directly inserted into multiple second quick connectors 4100 arranged in a row. Each electrode ring 9003 will compress the second elastic member 4130 in the corresponding second insertion cavity 4113. The second elastic member 4130 will provide elastic force, and the electrode body 9000 will be supported in the second insertion cavity 4113 under the action of this elastic force.

[0324] In an exemplary embodiment, the flexible circuit board 1000 is formed by laminating at least two flexible boards. The flexible circuit board 1000 is divided into a first board 5106 and a second board 5107. The flexible circuit board 1000 is provided with at least one spacer groove 5113, at least one boss 5109 and at least one insertion space 5112.

[0325] The spacer 5113 extends along the first direction (i.e. Figure 36 The spacer slot 5113 is positioned between the first board 5106 and the second board 5107 (in the x-axis direction). During the process of the gap 5111 expanding into the insertion space 5112, the spacer slot 5113 can ensure that the second board 5107 is not affected by the expansion process, thus ensuring the normal operation of the circuit on the second board 5107.

[0326] The number of bosses 5109 corresponds to the number of spacer slots 5113. The bosses 5109 are located on the first side portion 5108 of the first plate 5106 at positions corresponding to the spacer slots 5113.

[0327] The insertion space 5112 is disposed between two of the at least two flexible plates 5102 and 5103, and the insertion space 5112 is along the second direction (i.e. Figure 36 The y-axis direction of the plate passes through the first plate 5106 and the boss 5109 and connects to the corresponding spacer slot 5113. The insertion space 5112 is provided with a contact (not shown) that can be electrically connected to the electrode body 9000 to be inserted.

[0328] Each electrode body 9000 is housed in a corresponding insertion space 5112 and is electrically connected to a contact within the insertion space 5112.

[0329] The present invention allows the electrode body 9000 to be inserted into the insertion space 5112, and makes the electrode body 9000 electrically connected to the contacts within the insertion space 5112. While ensuring the electrical connection, the following effects are achieved:

[0330] On the one hand, the thickness of the insertion space 5112 directly includes the thickness of the flexible circuit board 1000, reducing the overall thickness and thus reducing the difficulty of installation.

[0331] On the other hand, the insertion space 5112 can be used with the electrode fixing seat to directly lock the inserted electrode body 9000. The insertion space 5112 replaces the original flexible connection terminal, avoiding magnetization by the nuclear magnetic resonance equipment and preventing positional movement. The material of the two flexible plates forming the insertion space 5112 is not affected by the nuclear magnetic resonance equipment, further reducing costs.

[0332] exist Figures 34 to 48In the implementation scheme, the number of electrode holders 5200 of the implantation device corresponds to the number of bosses 5109. The electrode holder 5200 is provided with a groove 5201 corresponding to the bosses 5109 and a cavity 5202 corresponding to the insertion space (see also...). Figure 43 , Figure 44 and Figure 47 The electrode holder 5200 is mounted on the first side 5108 of the first plate 5106 (see mating details). Figure 36 and Figure 37 And the boss 5109 is locked in the groove 5201 of the electrode holder 5200.

[0333] Each electrode body 9000 is housed in the cavity 5202 of a corresponding electrode holder 5200 and a corresponding insertion space 5112, and is electrically connected to the contacts in the insertion space 5112.

[0334] In an exemplary embodiment, the electrode body 9000 is provided with 8 electrode rings, the insertion space 5112 is provided with 7 contacts, and the electrode fixing seat 5200 is electrically connected to the flexible circuit board through the solder pad 5117. The 8 electrode rings provided on the electrode body 9000 correspond to the 7 contacts provided in the insertion space 5112 and the inner surface of the cavity 5202 of the electrode fixing seat 5200, and are electrically connected.

[0335] The number of bosses 5109 and insertion spaces 5112 are equal and can be adjusted according to the situation, for example, they can be set to any number from 1 to 4.

[0336] The number of slots 5113 can be equal to the number of gaps 5111, for example... Figure 42 In the middle, one slot 5113 corresponds to one gap 5111.

[0337] The number of slots 5113 can also be less than the number of gaps 5111, for example Figure 48 In this context, one slot 5113 can correspond to two gaps 5111.

[0338] exist Figure 42 and Figure 48 In the middle, the approximate location of gap 5111 is indicated by a dotted line.

[0339] The first plate 5106 and the second plate 5107 are integrated into one piece.

[0340] In an exemplary embodiment, a first side portion 5108 of the first board 5106 is provided with a pad 5117, and an electrode holder 5200 is soldered to the pad 5117.

[0341] The electrode holder 5200 is provided with a protrusion 5204 (see mating details). Figure 43 The protrusion 5204 of the electrode holder 5200 is welded to the pad 5117 of the first plate 5106.

[0342] In an exemplary implementation, such as Figure 36 and Figure 37 As shown, the implantable device further includes: an antenna plate 5114, which is integrally formed with the second plate 5107 and along a second direction (i.e., Figure 36 and Figure 37 (Extends along the y-axis).

[0343] In one embodiment, the length of antenna plate 5114 is less than the length of first plate 5106 (see also [reference]). Figure 39 ).

[0344] In another embodiment, the length of antenna plate 5114 is equal to the length of first plate 5106 (see also [reference]). Figure 42 ).

[0345] Antenna board 5114 can be fabricated through laser cutting, die stamping, or alternatively, a portion of the first board 5106 can be used directly as the antenna board without cutting the flexible circuit board 1000. For example, in Figure 40 In the middle, only one spacer slot 5113 is provided, and the part of the first plate 5106 that is away from the spacer slot 5113 in the positive x-axis direction can be used as the antenna plate 5114.

[0346] The antenna of the entire flexible circuit board 1000 is along the second direction (i.e. Figure 39 It extends along the y-axis and is arranged on the second plate 5107 and the antenna plate 5114.

[0347] In an exemplary implementation, such as Figure 45 and Figure 46 As shown, the conductive connection structure further includes a protective layer 5300, which wraps around the outside of the flexible circuit board 1000 and the electrode holder 5200.

[0348] The protective layer 5300 can be made of materials such as silicone, TPU, PGL, and PEEK, and formed through molding, injection molding, etc.

[0349] Figures 43 to 44 The electrode holder 5200 is just one type of electrode holder, and this type can be set in... Figures 15 to 19 Implementation plan Figures 20 to 24 Implementation plan and Figures 25 to 33 The implementation scheme is not limited to this type; it can be any form of existing technology, as long as it can achieve the above functions.

[0350] For ease of interpretation and precise definition of the appended claims, the terms “upper,” “lower,” “inner,” “outer,” “above,” “below,” “above,” “below,” “upward,” “downward,” “front,” “back,” “behind,” “inner side,” “outer side,” “inward,” “outer,” “internal,” “external,” “inner,” “external,” “forward,” and “backward” are used to describe the features of the exemplary embodiments with reference to the positions of these features shown in the accompanying drawings.

[0351] The foregoing description of specific exemplary embodiments of the invention is for illustrative and descriptive purposes. It is not intended to be exhaustive, nor to limit the invention to the precise forms disclosed; clearly, many changes and variations are possible in accordance with the foregoing teachings. The exemplary embodiments were chosen and described to explain the specific principles of the invention and its practical application, thereby enabling others skilled in the art to implement and utilize various exemplary embodiments of the invention, as well as their different alternatives and modifications. The scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A method for manufacturing an implantable device, characterized in that, include: a) Prepare a flexible circuit board, wherein the flexible circuit board is provided with at least one group of connection terminals; b) Prepare at least one electrode body, wherein each electrode body has a tail end electrode ring group at its proximal end and a head end electrode ring group at its distal end. c) Insert the proximal end of the electrode body into the corresponding connection terminal group of the flexible circuit board, so that the tail electrode ring group of the proximal end is electrically connected to the corresponding connection terminal group. The specific steps for preparing at least one electrode body include: b1) A packing tube is placed between the first tube body and the second tube body. The first tube body and the second tube body are connected by 2n wires. The 2n wires pass through 2n outer cavities of the first tube body and the second tube body respectively and surround the central cavity of the first tube body and the second tube body, so that the 2n wires surround the packing tube and the axis of the packing tube is aligned with the axis of the first tube body and the axis of the second tube body. b2) Insert the mandrel through the central cavity of the first tube, the packing tube, and the central cavity of the second tube so that the first tube, the packing tube, and the second tube come into contact in sequence. b3) Wrap the end of the first tube near the packing tube, the 2n wires and packing tube between the first tube and the second tube with a single-lumen tube; b4) Connect the first tube body, the packing tube, the second tube body and the single-lumen tube to each other. Step b4) includes: b41) Put heat shrink tubing on the outside of the first tube body, the single-lumen tube and the second tube body and heat it; b42) Peel off the heat shrink tubing and pull out the mandrel.

2. The method for manufacturing an implantable device according to claim 1, characterized in that, Step b1) further includes: b11) Provide a first tube body and a second tube body, wherein the first tube body and the second tube body each contain 2n+1 cavities extending along the axial direction of the tube body, wherein one central cavity is located at the axis of the tube body, and the remaining 2n peripheral cavities are distributed around the central cavity, where n is an integer greater than or equal to 1 and less than or equal to 8. b12) On the outer walls of the first tube and the second tube, 2n cuts are made along the axial and circumferential directions of the tube in a predetermined cutting sequence and at a predetermined cutting interval, and each cut exposes at least one peripheral lumen. b13) Insert 2n wires into the 2n outer cavities of the first tube and the second tube respectively; (b14) Take one end of 2n wires from the 2n incisions on the outer wall of the first tube and pull them out of the tube in a predetermined order, and connect them to the 2n head electrode rings respectively. Take the other end of 2n wires from the 2n incisions on the outer wall of the second tube and pull them out of the tube in a predetermined order, and connect them to the 2n tail electrode rings respectively. The 2n tail electrode rings form the tail electrode ring group of the proximal end, and the 2n head electrode rings form the head electrode ring group of the distal end.

3. The method for manufacturing an implantable device according to claim 2, characterized in that, Step b14) further includes: b141) Starting from the first incision furthest from the first tube body, pick out one end of the first wire in the first peripheral lumen; b142) Slide the first end electrode ring onto the distal end of the first tube body, so that the first end electrode ring wraps around the first tube body and covers the first cut, and is electrically connected to the protruding end of the first wire. b143) Repeat steps b141) and b142) until the 2n-end electrode ring covers the 2n-end cut of the first tube and is electrically connected to the protruding end of the 2n-end wire. b144) Starting from the first incision closest to the distal end of the second tube, pick out the other end of the first wire in the first peripheral lumen; b145) The first tail electrode ring is put on the proximal end of the second tube body, so that the first tail electrode ring is wrapped around the second tube body and covers the first cut, and is electrically connected to the other end of the first wire. (b146) Repeat steps b144) and b145) until the 2n tail electrode ring covers the 2n cut of the second tube and is electrically connected to the other end of the 2n wire.

4. The method for manufacturing an implantable device according to claim 3, characterized in that, The electrical connection between the electrode ring and the wire further includes: A metal ring is riveted to the protruding end of the wire, wherein the riveted metal ring is arc-shaped and its curved surface is consistent with the inner surface of the electrode ring. The metal ring is welded to the inner surface of the electrode ring.

5. The method for manufacturing an implantable device according to claim 1, characterized in that, The specific steps in fabricating a flexible circuit board include: A flexible connection terminal is prepared, the flexible connection terminal including a bracket and two flexible arc plates. The two flexible arc plates are disposed at the top of the bracket. The two flexible arc plates are recessed in a direction away from each other to form a clamping space. The two flexible arc plates can provide clamping force to the electrode body inserted into the clamping space. The plurality of the resilient connection terminals are soldered to the flexible circuit board to form at least one connection terminal group of the flexible circuit board.

6. The method for manufacturing an implantable device according to claim 1, characterized in that, The specific steps in fabricating a flexible circuit board include: A flexible circuit board is prepared, the flexible circuit board comprising at least two flexible plates, and at least one gap is formed between two of the at least two flexible plates, wherein a contact is disposed in the gap; Insert the separation tool into the gap, causing the gap to expand into an insertion space; After the insertion space is formed, the separation tool is removed, and each insertion space constitutes a connection terminal group.

7. The method for manufacturing an implantable device according to claim 1, characterized in that, The specific steps in fabricating a flexible circuit board include: A first quick connector is fabricated, comprising: a first connector body, a top bead, and a first elastic member. The first connector body has a first receiving cavity extending along a first direction and a first insertion cavity penetrating the first connector body along a second direction, the first receiving cavity communicating with the first insertion cavity; the top bead is disposed at a position in the first receiving cavity communicating with the first insertion cavity, and a portion of the top bead can extend into the first insertion cavity; the first elastic member is disposed within the first receiving cavity and provides elastic support force to the top bead. Multiple first quick connectors are soldered to a flexible circuit board to form at least one connection terminal group of the flexible circuit board.

8. The method for manufacturing an implantable device according to claim 1, characterized in that, The specific steps in fabricating a flexible circuit board include: A second quick connector is fabricated, comprising: a second connector body and a second elastic member. The second connector body is provided with a second insertion cavity penetrating a first surface and a second surface, a second receiving cavity communicating with the second insertion cavity, and support holes located on two opposite sidewalls of the second receiving cavity. The second elastic member includes an integrally formed arc-shaped plate and insertion plates disposed on both sides of the arc-shaped plate. The arc-shaped plate is disposed within the second receiving cavity, and a portion of the arc-shaped plate can extend into the second insertion cavity. Each insertion plate is disposed within a corresponding support hole. Multiple second quick connectors are soldered to the flexible circuit board to form at least one connection terminal group of the flexible circuit board.

9. The method for manufacturing an implantable device according to claim 1, characterized in that, Following the step of inserting the proximal end of the electrode into the corresponding connection terminal group of the flexible circuit board, the method of manufacturing the implantation device further includes: The electrode body is fixed on the flexible circuit board using an electrode holder.

10. An implantable device, characterized in that, include: A flexible circuit board, wherein at least one group of connection terminals is provided on the flexible circuit board; as well as At least one electrode body, each of the at least one electrode body has a tail end electrode ring group at its proximal end and a head end electrode ring group at its distal end. The proximal end of the electrode body can be inserted into the corresponding connection terminal group of the flexible circuit board, so that the tail electrode ring group of the proximal end is electrically connected to the corresponding connection terminal group. Each of the at least one electrode body includes: A first tube and a second tube are connected by 2n wires, which pass through 2n peripheral cavities of the first tube and the second tube respectively and surround the central cavity of the first tube and the second tube. A packing tube is located between a first tube body and a second tube body, and the axial position of the packing tube is aligned with the axial position of the first tube body and the axial position of the second tube body. 2n wires, the 2n wires being wound around the packing tube; A single-lumen tube, which encloses the end of the first tube body near the filler tube, 2n wires and the filler tube between the first tube body and the second tube body, and the end of the second tube body near the filler tube; The first tube body, the packing tube, the second tube body, and the single-lumen tube are integrated into one unit.

11. The implantation device according to claim 10, characterized in that, The first tube and the second tube each contain 2n+1 cavities extending along the axial direction of the tube, one of which is a central cavity located at the axis of the tube, and the remaining 2n peripheral cavities are distributed around the central cavity, where n is an integer greater than or equal to 1 and less than or equal to 8. The 2n wires are respectively inserted into the 2n peripheral cavities of the first tube and the second tube.

12. The implantation device according to claim 10, characterized in that, The first tube and the second tube each include: 2n incisions are formed on the outer wall of the tube in a predetermined order and at predetermined intervals along the axial and circumferential directions of the tube, with each incision exposing an outer peripheral lumen; 2n wires, each of which is inserted into one of the 2n peripheral lumens of the first tube and the second tube, and each has an exposed end that passes through a cut in the peripheral lumen; and 2n electrode rings are sequentially and alternately fitted onto the outer wall of the tube and each ring covers 2n slits, thereby electrically connecting to the exposed ends of 2n wires respectively. Among them, the 2n electrode rings located on the first tube are the head electrode rings, which form the head electrode ring group at the distal end, and the 2n electrode rings located on the second tube are the tail electrode rings, which form the tail electrode ring group at the proximal end.

13. The implantation device according to claim 12, characterized in that, The wire is electrically connected to the corresponding electrode ring via a crimping component; The riveting component is a metal ring riveted into an arc shape, the curved surface of the metal ring is consistent with the inner surface of the electrode ring and is welded to the inner surface of the electrode ring.

14. The implantation device according to claim 10, characterized in that, Each of the at least one connection terminal group includes a plurality of resilient connection terminals, each resilient connection terminal including: stents; and Two elastic arc-shaped plates are disposed at the top of the bracket. Each of the two elastic arc-shaped plates is recessed in a direction away from each other to form a clamping space, and the two elastic arc-shaped plates can provide clamping force to the electrode body inserted into the clamping space.

15. The implantation device according to claim 10, characterized in that, The flexible circuit board is formed by laminating at least two flexible boards, and the flexible circuit board is divided into a first board and a second board. The flexible circuit board is provided with: At least one spacer groove extends along a first direction and is disposed between the first plate and the second plate; At least one boss is provided on a first side of the first plate at a position corresponding to the spacer groove; At least one insertion space is disposed between two of the at least two flexible plates, the insertion space passing through the first plate and the boss along a second direction and communicating with the corresponding spacer slot, and the insertion space is provided with a contact capable of electrically connecting with the electrode body to be inserted.

16. The implantation device according to claim 10, characterized in that, At least one connection terminal group, each of which includes a plurality of first quick connectors, each first quick connector including: The first connector body has a first receiving cavity extending in a first direction and a first insertion cavity penetrating the first connector body in a second direction, wherein the first receiving cavity is connected to the first insertion cavity. A top bead, disposed in the first receiving cavity at a position communicating with the first insertion cavity, and a portion of the top bead extending into the first insertion cavity; and A first elastic member is disposed within the first receiving cavity and provides elastic support for the top bead.

17. The implantation device according to claim 10, characterized in that, At least one connection terminal group, each of which includes a plurality of second quick connectors, each second quick connector including: The second connecting seat body has a second insertion cavity penetrating through a first surface and a second surface, a second receiving cavity communicating with the second insertion cavity, and support holes located on two opposite sidewalls of the second receiving cavity; and The second elastic member includes an integrally formed arcuate plate and plug-in plates disposed on both sides of the arcuate plate. The arcuate plate is disposed within a second receiving cavity, and a portion of the arcuate plate can extend into the second plug-in cavity. Each plug-in plate is disposed within a corresponding support hole.

18. The implantation device according to claim 10, characterized in that, The implantable device further includes: An electrode holder is mounted to the flexible circuit board and is used to fix the electrode body on the flexible circuit board.

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